LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
Report
- Report Number
- 2522007-2024-00030
- Event Type
- Death
- Date Received
- August 23, 2024
- Date of Event
- August 20, 2024
- Report Date
- November 14, 2024
- Manufacturer
- COOK VANDERGRIFT INC
- Product Code
- DRB
- UDI-DI
- 10827002265506
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLANK FIELDS ON THIS FORM INDICATED THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. THE EVENT IS CURRENTLY UNDER INVESTIGATION. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE OR UPON COMPLETION OF INVESTIGATION. G5 ¿ PMA/510(K): K170298. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
THE UDI INFORMATION PER 21CFR 803.52(C)(4) AND 21 CFR 803.50(B) THAT IS REQUIRED IS REASONABLY UNKNOWN DUE TO THE DEVICE ITSELF WAS DISCARDED/NOT RETURNED FOR INVESTIGATION AFTER MANUFACTURER REQUESTED FOR THE RETURN AND THE LOT OF THE DEVICE WAS KNOWN. G5 ¿ PMA/510(K): K170298. THE DEVICE WAS NOT RETURNED FOR THE COMPLAINT; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED, AND THE CUSTOMER'S COMPLAINT IS ACKNOWLEDGED, BUT COULD NOT BE CONFIRMED, OTHER THAN BY THE CUSTOMER'S TESTIMONY. THE COMPLAINT/EVENT THAT WAS ENTERED AND REPORTED WITHIN TRACKWISE: "SUSPECTED PULMONARY EMBOLISM." WITHIN THE COMPLAINT ITSELF, IT WAS STATED THAT THE SURGEON SAID THAT "THE CAUSE FOR THE PATIENT'S DEATH HAD BEEN DAMAGE TO THE AREA BETWEEN THE SUBCLAVIAN VEIN AND THE SUPERIOR VENA CAVA, AND THAT CAUSE OF THIS DAMAGE COULD NOT BE DETERMINED." AND "I THINK THAT A CLOT MAY HAVE BEEN BLOWN OFF WHEN THE LASER SHEATH WAS BEING MOVED TO RETRACT THE RV LEAD INTO THE OUTER SHEATH OF THE LASER SHEATH IN THE FINAL STAGE." THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED. THERE WERE NO SIGNS THAT THE DEVICE WAS NONCONFORMING OR THAT THE DEVICE WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS. THIS COMPLAINT MODE WILL BE TRACKED, TRENDED AND MONITORED IN CVI COMPLAINT HANDLING AND POST MARKET SURVEILLANCE PROCEDURES. A RISK ASSESSMENT WILL BE PERFORMED WITHIN THE COMPLAINT SUMMARY TAB OF TRACKWISE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
THE UDI INFORMATION PER 21CFR 803.52(C)(4) AND 21 CFR 803.50(B) THAT IS REQUIRED IS REASONABLY UNKNOWN DUE TO THE DEVICE ITSELF WAS DISCARDED/NOT RETURNED FOR INVESTIGATION AFTER MANUFACTURER REQUESTED FOR THE RETURN AND THE LOT OF THE DEVICE WAS KNOWN. E3 - OCCUPATION: DOCTOR. G5 ¿ PMA/510(K): K170298. THE EVENT IS CURRENTLY UNDER INVESTIGATION. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE OR UPON COMPLETION OF INVESTIGATION. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
DEVICES INVOLVED: LR-OFA01 (LOT N205140) --- APPROACHED FROM THE LEFT SUBCLAVIAN VEIN FOR RV LEAD. LR-NES001 (LOT N199524) --- APPROACHED FROM THE LEFT SUBCLAVIAN VEIN FOR RV LEAD. LR-EVN-SH-9.0-RL (LOT N202627) --- APPROACHED FROM THE LEFT SUBCLAVIAN VEIN FOR RV LEAD. LR-PPLBES-10.0 (LOT N202202) --- APPROACHED FROM THE LEFT SUBCLAVIAN VEIN FOR RV LEAD. PHILIPS / 518-067 / LEAD LOCKING DEVICE KIT (LOT FLK24C05A). PHILIPS /500-303 / GLIDELIGHT LASER SHEATH 16FR (LOT FGC22K05A). SHORTLY AFTER SUCCESSFULLY COMPLETING TLE (TRANSVENOUS LEAD EXTRACTION), THE PATIENT'S BLOOD PRESSURE DROPPED TO THE 50S. TRANSESOPHAGEAL ECHOCARDIOGRAPHY WAS PERFORMED TO CHECK FOR PERICARDIAL EFFUSION, BUT THERE WAS NO CHANGE FROM BEFORE SURGERY. ANGIOGRAPHY OF THE SVC (SUPERIOR VENA CAVA) WAS PERFORMED, BUT THERE WAS NO INDICATION OF DAMAGE TO THE SVC. AT THE SURGEON'S INSTRUCTION, THE PATIENT WAS CONNECTED TO PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS), AND HER BLOOD PRESSURE IMPROVED FROM THE 40S TO THE 100S. THE SURGEONS DIAGNOSED HER WITH A SUSPECTED PULMONARY EMBOLISM. THE PATIENT WAS CONNECTED TO PCPS AND RETURNED TO THE ICU AFTER SURGERY. HER CONDITION WILL BE IMPROVED BY ADMINISTERING MEDICATION.
DEVICES INVOLVED: LR-OFA01 (LOT N205140) --- APPROACHED FROM THE LEFT SUBCLAVIAN VEIN FOR RV LEAD. LR-NES001 (LOT N199524) --- APPROACHED FROM THE LEFT SUBCLAVIAN VEIN FOR RV LEAD. LR-EVN-SH-9.0-RL (LOT N202627) --- APPROACHED FROM THE LEFT SUBCLAVIAN VEIN FOR RV LEAD. LR-PPLBES-10.0 (LOT N202202) --- APPROACHED FROM THE LEFT SUBCLAVIAN VEIN FOR RV LEAD. PHILIPS /500-303 / GLIDELIGHT LASER SHEATH 16FR (LOT FGC22K05A). SHORTLY AFTER SUCCESSFULLY COMPLETING TLE (TRANSVENOUS LEAD EXTRACTION), THE PATIENT'S BLOOD PRESSURE DROPPED TO THE 50S. TRANSESOPHAGEAL ECHOCARDIOGRAPHY WAS PERFORMED TO CHECK FOR PERICARDIAL EFFUSION, BUT THERE WAS NO CHANGE FROM BEFORE SURGERY. ANGIOGRAPHY OF THE SVC (SUPERIOR VENA CAVA) WAS PERFORMED, BUT THERE WAS NO INDICATION OF DAMAGE TO THE SVC. AT THE SURGEON'S INSTRUCTION, THE PATIENT WAS CONNECTED TO PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS), AND HER BLOOD PRESSURE IMPROVED FROM THE 40S TO THE 100S. THE SURGEONS DIAGNOSED HER WITH A SUSPECTED PULMONARY EMBOLISM. THE PATIENT WAS CONNECTED TO PCPS AND RETURNED TO THE ICU AFTER SURGERY. HER CONDITION WILL BE IMPROVED BY ADMINISTERING MEDICATION. UPDATED ON 22AUG2024: ADDITIONAL INFORMATION FROM THE EMAIL CORRESPONDENCE BETWEEN CMJ VR TEAM AND THE SALES REP. 1. WERE COOK PRODUCTS USED ON THE RV LEAD? YES. THE LIBERATOR WAS INSERTED INTO THE STYLET LUMEN OF THE LEAD AND SECURED IN PLACE. THE RV LEAD WAS FIRST REMOVED FROM THE ADHESIVE TISSUE USING AN EVOLUTION 9FR SHORTIE AND ITS ATTACHED OUTER SHEATH FROM THE INSERTION SITE TO HALFWAY UP THE INNOMINATE VEIN. AFTERWARDS THERE WAS NO REMOVAL OF ADHESIVE TISSUE FROM THE RV LEAD USING COOK PRODUCTS. THE SURGEON THEN CHANGED TO AN EXCIMER LASER SHEATH OF 14FR (GLIDELIGHT 14FR) AND CONTINUED THE REMOVAL OF ADHESIVE TISSUE, UNTIL HE REACHED THE PROXIMAL PART OF THE SVC. AFTER CHANGING TO A 16FR EXCIMER LASER (GLIDELIGHT 16FR), WHILE HE WAS REMOVING THE ADHESION TISSUE IN THE MIDDLE OF THE SVC, HE FELT AS IF THE WIRE INSIDE THE LEAD HAD BROKEN, AND THE LIBERATOR CAME OUT. SUBSEQUENTLY, THE OUTER SHEATH WAS PLACED ONTO THE GLIDELIGHT 16FR AND THE ADHESION TISSUE WAS REMOVED, AND THE TIP OF THE LEAD CAME OFF. WHEN THE SURGEON IN CHARGE TRIED TO PULL THE LEAD TO RETRACT IT INTO THE SHEATH, THE LEAD WAS RETRACTED INTO THE OUTER SHEATH AND THEN REMOVED. THE PATIENT'S BLOOD PRESSURE DROPPED SHORTLY AFTER THE LEAD REMOVAL. 2. IN THIS CASE, IT APPEARS THAT A PHILIPS LOCKING STYLET AND A COOK LOCKING STYLET WERE USED, BUT HOW MANY RV LEADS WERE TO BE REMOVED IN TOTAL? I WAS MISTAKEN. THERE WAS ONLY ONE RV LEAD TO BE REMOVED. (THERE WAS NO RV LEAD REMOVED BY PHILIPS LOCKING STYLET.) 3. WAS THE RV LEAD STORED INSIDE THE OUTER SHEATH OF THE LASER SHEATH WHILE THE COOK PRODUCT WAS STILL INSIDE THE PATIENT? THE COOK PRODUCT WAS NOT IN THE PATIENT'S BODY. ONLY THE GLIDELIGHT 16FR AND THE OUTER SHEATH WERE IN THE PATIENT'S BODY. ADDITIONAL INFORMATION PROVIDED BY THE REP ON 23AUG2024: BLOOD LEAKAGE FROM THE SVC WAS CONFIRMED BY CONTRAST-ENHANCED CT. IT'S UNKNOWN IF SURGICAL TREATMENT WILL BE CONDUCTED. PCPS WAS ONCE REMOVED, BUT IT WILL BE CONNECTED TO THE PATIENT AGAIN. UPDATED ON 02SEP2024: AFTER THE START OF THE SURGERY, NES001 GRABBED THE LEADS RUNNING THROUGH THE SVC. IT APPEARED TO GRAB BOTH THE RA LEAD AND THE RV LEAD. THE OFA WAS THEN INSERTED INTO THE RV LEAD, AND THE OFA WAS INSERTED UP TO THE TIP OF THE LEAD AND FIXED. THE OUTER SHEATH WAS PLACED ON THE EVOLUTION SHORTIE 9FR AND INSERTED THROUGH THE INSERTION SITE ALONG THE RV LEAD. THE CATHETER WAS CHANGED TO A GLIDELIGHT 14FR AND THE ADHESION TISSUE WAS REMOVED UP TO THE SVC AREA. THE SHEATH WAS UNCHANGED AND A BYRD 10FR WAS USED FOR THE RA LEAD. SINCE SOME OF THE ADHESIONS IN THE SVC PART OF THE RA LEAD HAD COME LOOSE, THE SURGEON TRIED TO ADVANCE THE GLIDELIGHT IN THE RV LEAD, BUT THERE FELT LIKE THERE WAS A LUMP AND THE GLIDELIGHT WOULD NOT ADVANCE. AT THIS POINT THE NES HAS COME OFF. THE SURGEON CHANGED THE GLIDELIGHT14FR TO THE GLIDELIGHT16FR. IT FELT LIKE THE WIRE GOT BROKEN IN THE SVC SECTION. AND THE OFA CAME LOOSE. AN ATTEMPT WAS MADE TO SET THE OUTER SHEATH ON THE GLIDELIGHT 16FR TO DISSECT THE ADHESION TISSUE, BUT IT DID NOT ADVANCE IN THE SVC AREA. THE SURGEON ATTEMPTED TO ADVANCE THE BYRD 10FR OUTER SHEATH, BUT THERE WAS SEVERE BACKFLOW, SO IT WAS IMMEDIATELY REMOVED. WHEN IT WAS CHANGED TO GLIDELIGHT 16FR, THE TIP OF THE RV LEAD CAME OFF. WHEN THE SURGEON SET THE OUTER SHEATH ON THE GLIDELIGHT 16FR AND ADVANCED IT, THE LEAD RETRACTED AND WAS STORED INSIDE THE OUTER SHEATH. SHORTLY AFTER SUCCESSFULLY COMPLETING TLE (TRANSVENOUS LEAD EXTRACTION), THE PATIENT'S BLOOD PRESSURE DROPPED TO THE 50S. TRANSESOPHAGEAL ECHOCARDIOGRAPHY WAS PERFORMED TO CHECK FOR PERICARDIAL EFFUSION, BUT THERE WAS NO CHANGE FROM BEFORE SURGERY. ANGIOGRAPHY OF THE SVC (SUPERIOR VENA CAVA) WAS PERFORMED, BUT THERE WAS NO INDICATION OF DAMAGE TO THE SVC. AT THE SURGEON'S INSTRUCTION, THE PATIENT WAS CONNECTED TO PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS), AND HER BLOOD PRESSURE IMPROVED FROM THE 40S TO THE 100S. THE SURGEONS DIAGNOSED HER WITH A SUSPECTED PULMONARY EMBOLISM. THE PATIENT WAS CONNECTED TO PCPS AND RETURNED TO THE ICU AFTER SURGERY. BLOOD LEAKAGE FROM THE SVC WAS CONFIRMED BY CONTRAST-ENHANCED CT (ADDITIONAL INFO FROM THE REP ON 23AUG2024). IT'S UNKNOWN IF SURGICAL TREATMENT WILL BE CONDUCTED. PCPS WAS ONCE REMOVED, BUT IT WILL BE CONNECTED TO THE PATIENT AGAIN. UPDATED ON 04SEP2024: ON THE (B)(6), THE SALES REP RECEIVED A MESSAGE FROM THE AGENCY REP SAYING, "THE PATIENT'S BLOOD PRESSURE DID NOT RETURN TO NORMAL AND SURGERY WAS NOT POSSIBLE, SO SHE PASSED AWAY LAST WEEK." AFTER AN INVESTIGATION, IT WAS DETERMINED THAT THE SVC HAD TORN. UPDATED ON 19SEP2024: ADDITIONAL INFORMATION FROM THE EMAIL CORRESPONDENCE BETWEEN CMJ VR TEAM AND THE SALES REP. Q1. BEFORE THE PATIENT DIED, DID HER BLOOD PRESSURE, WHICH HAD RECOVERED TO THE 100S, DROP AGAIN AND WAS SHE RECONNECTED TO PCPS? WHEN THE PCPS WAS FIRST CONNECTED, THE PATIENT'S BLOOD PRESSURE RECOVERED TO THE 100S, BUT IT DROPPED AFTER A WHILE, AND I RECALL THAT IT WAS BELOW 100 BY THE TIME THE PATIENT LEFT THE OPERATING ROOM. I HAVE NOT CONFIRMED WHETHER THE PCPS WAS DISCONNECTED AND THEN RECONNECTED. Q2. WHAT DOES THE SURGEON THINK WAS THE DIRECT CAUSE OF DEATH? (SUSPECTED PULMONARY EMBOLISM, BLOOD LEAKAGE FROM THE SVC, ASSOCIATED DROP IN BLOOD PRESSURE, OR ALL THREE OF THESE?) WHAT I HEARD DIRECTLY FROM THE SURGEON WAS THAT THERE WAS A SUSPICION OF PULMONARY EMBOLISM ON THE DAY OF THE OPERATION. THAT WAS THE ONLY OPINION I HEARD DIRECTLY FROM THE SURGEON. WHAT I HEARD FROM THE AGENCY STAFF WITHIN THE HOSPITAL AFTERWARDS WAS THAT A CONTRAST CT SCAN CONFIRMED A LEAK FROM THE SVC, AND THAT THIS WAS PROBABLY ACCOMPANIED BY A DROP IN BLOOD PRESSURE (IT MIGHT BE MORE ACCURATE TO SAY THAT IT DID NOT RISE ENOUGH). Q3. PLEASE TELL US WHAT THE SURGEON THINKS ARE THE CAUSES OF THE DEATH OF THE PATIENT. WHEN THE AGENCY STAFF ASKED THE SURGEON, HE SAID THAT THE CAUSE OF THE PATIENT'S DEATH HAD BEEN DAMAGE TO THE AREA BETWEEN THE SUBCLAVIAN VEIN AND THE SUPERIOR VENA CAVA, AND THE CAUSE OF THIS DAMAGE COULD NOT BE DETERMINED.
DEVICES INVOLVED: LR-OFA01 (LOT N205140) --- APPROACHED FROM THE LEFT SUBCLAVIAN VEIN FOR RV LEAD. LR-NES001 (LOT N199524) --- APPROACHED FROM THE LEFT SUBCLAVIAN VEIN FOR RV LEAD. LR-EVN-SH-9.0-RL (LOT N202627) --- APPROACHED FROM THE LEFT SUBCLAVIAN VEIN FOR RV LEAD. LR-PPLBES-10.0 (LOT N202202) --- APPROACHED FROM THE LEFT SUBCLAVIAN VEIN FOR RV LEAD. PHILIPS /500-303 / GLIDELIGHT LASER SHEATH 16FR (LOT FGC22K05A). SHORTLY AFTER SUCCESSFULLY COMPLETING TLE (TRANSVENOUS LEAD EXTRACTION), THE PATIENT'S BLOOD PRESSURE DROPPED TO THE 50S. TRANSESOPHAGEAL ECHOCARDIOGRAPHY WAS PERFORMED TO CHECK FOR PERICARDIAL EFFUSION, BUT THERE WAS NO CHANGE FROM BEFORE SURGERY. ANGIOGRAPHY OF THE SVC (SUPERIOR VENA CAVA) WAS PERFORMED, BUT THERE WAS NO INDICATION OF DAMAGE TO THE SVC. AT THE SURGEON'S INSTRUCTION, THE PATIENT WAS CONNECTED TO PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS), AND HER BLOOD PRESSURE IMPROVED FROM THE 40S TO THE 100S. THE SURGEONS DIAGNOSED HER WITH A SUSPECTED PULMONARY EMBOLISM. THE PATIENT WAS CONNECTED TO PCPS AND RETURNED TO THE ICU AFTER SURGERY. HER CONDITION WILL BE IMPROVED BY ADMINISTERING MEDICATION. UPDATED ON 22AUG2024: ADDITIONAL INFORMATION FROM THE EMAIL CORRESPONDENCE BETWEEN CMJ VR TEAM AND THE SALES REP. 1. WERE COOK PRODUCTS USED ON THE RV LEAD? YES. THE LIBERATOR WAS INSERTED INTO THE STYLET LUMEN OF THE LEAD AND SECURED IN PLACE. THE RV LEAD WAS FIRST REMOVED FROM THE ADHESIVE TISSUE USING AN EVOLUTION 9FR SHORTIE AND ITS ATTACHED OUTER SHEATH FROM THE INSERTION SITE TO HALFWAY UP THE INNOMINATE VEIN. AFTERWARDS THERE WAS NO REMOVAL OF ADHESIVE TISSUE FROM THE RV LEAD USING COOK PRODUCTS. THE SURGEON THEN CHANGED TO AN EXCIMER LASER SHEATH OF 14FR (GLIDELIGHT 14FR) AND CONTINUED THE REMOVAL OF ADHESIVE TISSUE, UNTIL HE REACHED THE PROXIMAL PART OF THE SVC. AFTER CHANGING TO A 16FR EXCIMER LASER (GLIDELIGHT 16FR), WHILE HE WAS REMOVING THE ADHESION TISSUE IN THE MIDDLE OF THE SVC, HE FELT AS IF THE WIRE INSIDE THE LEAD HAD BROKEN, AND THE LIBERATOR CAME OUT. SUBSEQUENTLY, THE OUTER SHEATH WAS PLACED ONTO THE GLIDELIGHT 16FR AND THE ADHESION TISSUE WAS REMOVED, AND THE TIP OF THE LEAD CAME OFF. WHEN THE SURGEON IN CHARGE TRIED TO PULL THE LEAD TO RETRACT IT INTO THE SHEATH, THE LEAD WAS RETRACTED INTO THE OUTER SHEATH AND THEN REMOVED. THE PATIENT'S BLOOD PRESSURE DROPPED SHORTLY AFTER THE LEAD REMOVAL. 2. IN THIS CASE, IT APPEARS THAT A PHILIPS LOCKING STYLET AND A COOK LOCKING STYLET WERE USED, BUT HOW MANY RV LEADS WERE TO BE REMOVED IN TOTAL? I WAS MISTAKEN. THERE WAS ONLY ONE RV LEAD TO BE REMOVED. (THERE WAS NO RV LEAD REMOVED BY PHILIPS LOCKING STYLET.) 3. WAS THE RV LEAD STORED INSIDE THE OUTER SHEATH OF THE LASER SHEATH WHILE THE COOK PRODUCT WAS STILL INSIDE THE PATIENT? THE COOK PRODUCT WAS NOT IN THE PATIENT'S BODY. ONLY THE GLIDELIGHT 16FR AND THE OUTER SHEATH WERE IN THE PATIENT'S BODY. ADDITIONAL INFORMATION PROVIDED BY THE REP ON 23AUG2024: BLOOD LEAKAGE FROM THE SVC WAS CONFIRMED BY CONTRAST-ENHANCED CT. IT'S UNKNOWN IF SURGICAL TREATMENT WILL BE CONDUCTED. PCPS WAS ONCE REMOVED, BUT IT WILL BE CONNECTED TO THE PATIENT AGAIN. UPDATED ON 02SEP2024: AFTER THE START OF THE SURGERY, NES001 GRABBED THE LEADS RUNNING THROUGH THE SVC. IT APPEARED TO GRAB BOTH THE RA LEAD AND THE RV LEAD. THE OFA WAS THEN INSERTED INTO THE RV LEAD, AND THE OFA WAS INSERTED UP TO THE TIP OF THE LEAD AND FIXED. THE OUTER SHEATH WAS PLACED ON THE EVOLUTION SHORTIE 9FR AND INSERTED THROUGH THE INSERTION SITE ALONG THE RV LEAD. THE CATHETER WAS CHANGED TO A GLIDELIGHT 14FR AND THE ADHESION TISSUE WAS REMOVED UP TO THE SVC AREA. THE SHEATH WAS UNCHANGED AND A BYRD 10FR WAS USED FOR THE RA LEAD. SINCE SOME OF THE ADHESIONS IN THE SVC PART OF THE RA LEAD HAD COME LOOSE, THE SURGEON TRIED TO ADVANCE THE GLIDELIGHT IN THE RV LEAD, BUT THERE FELT LIKE THERE WAS A LUMP AND THE GLIDELIGHT WOULD NOT ADVANCE. AT THIS POINT THE NES HAS COME OFF. THE SURGEON CHANGED THE GLIDELIGHT14FR TO THE GLIDELIGHT16FR. IT FELT LIKE THE WIRE GOT BROKEN IN THE SVC SECTION. AND THE OFA CAME LOOSE. AN ATTEMPT WAS MADE TO SET THE OUTER SHEATH ON THE GLIDELIGHT 16FR TO DISSECT THE ADHESION TISSUE, BUT IT DID NOT ADVANCE IN THE SVC AREA. THE SURGEON ATTEMPTED TO ADVANCE THE BYRD 10FR OUTER SHEATH, BUT THERE WAS SEVERE BACKFLOW, SO IT WAS IMMEDIATELY REMOVED. WHEN IT WAS CHANGED TO GLIDELIGHT 16FR, THE TIP OF THE RV LEAD CAME OFF. WHEN THE SURGEON SET THE OUTER SHEATH ON THE GLIDELIGHT 16FR AND ADVANCED IT, THE LEAD RETRACTED AND WAS STORED INSIDE THE OUTER SHEATH. SHORTLY AFTER SUCCESSFULLY COMPLETING TLE (TRANSVENOUS LEAD EXTRACTION), THE PATIENT'S BLOOD PRESSURE DROPPED TO THE 50S. TRANSESOPHAGEAL ECHOCARDIOGRAPHY WAS PERFORMED TO CHECK FOR PERICARDIAL EFFUSION, BUT THERE WAS NO CHANGE FROM BEFORE SURGERY. ANGIOGRAPHY OF THE SVC (SUPERIOR VENA CAVA) WAS PERFORMED, BUT THERE WAS NO INDICATION OF DAMAGE TO THE SVC. AT THE SURGEON'S INSTRUCTION, THE PATIENT WAS CONNECTED TO PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS), AND HER BLOOD PRESSURE IMPROVED FROM THE 40S TO THE 100S. THE SURGEONS DIAGNOSED HER WITH A SUSPECTED PULMONARY EMBOLISM. THE PATIENT WAS CONNECTED TO PCPS AND RETURNED TO THE ICU AFTER SURGERY. BLOOD LEAKAGE FROM THE SVC WAS CONFIRMED BY CONTRAST-ENHANCED CT (ADDITIONAL INFO FROM THE REP ON 23AUG2024). IT'S UNKNOWN IF SURGICAL TREATMENT WILL BE CONDUCTED. PCPS WAS ONCE REMOVED, BUT IT WILL BE CONNECTED TO THE PATIENT AGAIN. UPDATED ON 04SEP2024: ON THE (B)(6), THE SALES REP RECEIVED A MESSAGE FROM THE AGENCY REP SAYING, "THE PATIENT'S BLOOD PRESSURE DID NOT RETURN TO NORMAL AND SURGERY WAS NOT POSSIBLE, SO SHE PASSED AWAY LAST WEEK." AFTER AN INVESTIGATION, IT WAS DETERMINED THAT THE SVC HAD TORN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1387417 | LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET | DRB STYLET, CATHETER | DRB | COOK VANDERGRIFT INC | G26550 | N205140 | 10827002265506 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Female | Other| D | LR-EVN-SH-9.0-RL| LR-NES001| LR-PPLBES-10.0| PHILIPS/500-303/GLIDELIGHT LASER SHEATH 16FR |