LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
Report
- Report Number
- 2522007-2024-00001
- Event Type
- Injury
- Date Received
- February 12, 2024
- Date of Event
- January 17, 2024
- Report Date
- August 27, 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
CORRECTED DATA (B)(6) 2024 AHE PER THE FOLLOWING D4 - UDI: THE UDI INFORMATION PER 21CFR 803.52(C)(4) AND 21 CFR 803.50(B) THAT IS REQUIRED HAS BEEN ADDED/UPDATED TO THIS REPORT: D2A: DRB STYLET, CATHETER, D2B: DRB, D4 MODEL: G26550. ONE USED/OPENED/NOT STERILE LR-OFA01 DEVICE WAS RETURNED ON THIS COMPLAINT. THE CUSTOMER COMPLAINT/EVENT THAT WAS ENTERED INTO TRACKWISE: "THE LIBERATOR CAME COMPLETELY OUT OF THE LUMEN OF THE LEAD." THE QUALITY ASSURANCE DEPARTMENT INVESTIGATED THE RETURNED PRODUCT. VISUALLY THE DEVICE WAS RETURNED IN THE PLASTIC TUBING, HOWEVER IT WAS NOT IN THE PACKAGING, THERE WAS BLOOD THROUGHOUT THE DEVICE ITSELF, THERE WERE MANY KINKS WITHIN THE DEVICE, WHICH IS UNKNOWN IF DUE TO PACKAGING, BUT NOTED THE KINKS, THERE WAS THE DISTAL END MISSING, AND THE HANDLE WAS ATTACHED TO THE CANNULA-NO LATCH PIN RETURNED THOUGH. THE CUSTOMER'S COMPLAINT WAS ACKNOWLEDGED; HOWEVER IT IS UNCERTAIN AS TO WHAT MAY HAVE CAUSED THE CUSTOMER COMPLAINT. VISUALLY THE ENGINEERING DEPARTMENT ASSISTED WITH THE INVESTIGATION OF THE COMPLAINT. VISUALLY THE DEVICE SHOWED A DUCTILE FRACTURE WHICH MAY HAVE BEEN CAUSED FROM EXCESSIVE FORCE ON THE STYLET WIRE ITSELF. THE COMPLAINT CAN ONLY BE CONFIRMED BY THE CUSTOMER'S TESTIMONY SPECIFIC TO THE LIBERATOR COMING OUT OF THE LUMEN OF THE LEAD. PER COMPLAINT INFORMATION, "....ATTEMPT WAS MADE TO RECOVER LEAD FRAGMENT DURING THE EXTRACTION PROCEDURE BUT WAS ABANDONED WHEN THE PATIENT BEGAN SHOWING SIGNS OF HYPOTENSION." THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, INCLUDING MANUFACTURING AND QUALITY CONTROL RECORDS AND THERE ARE NO SIGNS TO INDICATE THAT THE DEVICE WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS. THIS COMPLAINT MODE IS BEING MONITORED, TRACKED AND TRENDED PER THE CVI POST MARKET SURVEILLANCE AND COMPLAINT HANDLING PROCESSES. A RISK ASSESSMENT WILL BE PERFORMED AND DOCUMENTED IN THE COMPLAINT SUMMARY TAB IN TRACKWISE. 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.
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.
ONE USED/OPENED/NOT STERILE LR-OFA01 DEVICE WAS RETURNED ON THIS COMPLAINT. THE CUSTOMER COMPLAINT/EVENT THAT WAS ENTERED INTO TRACKWISE: "THE LIBERATOR CAME COMPLETELY OUT OF THE LUMEN OF THE LEAD." THE QUALITY ASSURANCE DEPARTMENT INVESTIGATED THE RETURNED PRODUCT. VISUALLY THE DEVICE WAS RETURNED IN THE PLASTIC TUBING, HOWEVER IT WAS NOT IN THE PACKAGING, THERE WAS BLOOD THROUGHOUT THE DEVICE ITSELF, THERE WERE MANY KINKS WITHIN THE DEVICE, WHICH IS UNKNOWN IF DUE TO PACKAGING, BUT NOTED THE KINKS, THERE WAS THE DISTAL END MISSING, AND THE HANDLE WAS ATTACHED TO THE CANNULA-NO LATCH PIN RETURNED THOUGH. THE CUSTOMER'S COMPLAINT WAS ACKNOWLEDGED; HOWEVER IT IS UNCERTAIN AS TO WHAT MAY HAVE CAUSED THE CUSTOMER COMPLAINT. VISUALLY THE ENGINEERING DEPARTMENT ASSISTED WITH THE INVESTIGATION OF THE COMPLAINT. VISUALLY THE DEVICE SHOWED A DUCTILE FRACTURE WHICH MAY HAVE BEEN CAUSED FROM EXCESSIVE FORCE ON THE STYLET WIRE ITSELF. THE COMPLAINT CAN ONLY BE CONFIRMED BY THE CUSTOMER'S TESTIMONY SPECIFIC TO THE LIBERATOR COMING OUT OF THE LUMEN OF THE LEAD. PER COMPLAINT INFORMATION, "....ATTEMPT WAS MADE TO RECOVER LEAD FRAGMENT DURING THE EXTRACTION PROCEDURE BUT WAS ABANDONED WHEN THE PATIENT BEGAN SHOWING SIGNS OF HYPOTENSION." THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, INCLUDING MANUFACTURING AND QUALITY CONTROL RECORDS AND THERE ARE NO SIGNS TO INDICATE THAT THE DEVICE WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS. THIS COMPLAINT MODE IS BEING MONITORED, TRACKED AND TRENDED PER THE CVI POST MARKET SURVEILLANCE AND COMPLAINT HANDLING PROCESSES. A RISK ASSESSMENT WILL BE PERFORMED AND DOCUMENTED IN THE COMPLAINT SUMMARY TAB IN TRACKWISE. 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.
PER EMAIL RECEIVED ON (B)(6)2024: SHE UNDERWENT A SURGICAL PROCEDURE AS AN INFANT KNOWN AS A MUSTARD PROCEDURE, WHICH AT THE TIME, WAS THE ACCEPTED METHOD OF CORRECTING THE BLOOD FLOW, BUT HAD THE ADDED COMPLICATION OF THE PACEMAKER LEADS BEING IN THE LEFT ATRIUM AND VENTRICLE. SHE HAD A MEDTRONIC 4057 PACEMAKER LEAD PLACED IN 1993 AT 9 YEARS OLD, WHICH CLEARLY FRACTURED AND WAS ABANDONED, REQUIRING A NEW SYSTEM IN 2005 (LA GUIDANT 4470, LV MDT 5076). RECENTLY, THE 4470 ATRIAL LEAD BEGAN MALFUNCTIONING AND BEING PACING DEPENDENT, REQUIRED ANOTHER REVISION. THE LEFT BRACHIOCEPHALIC VEIN CONTAINING THE LEADS WAS COMPLETELY OCCLUDED WITH CONSIDERABLE COLLATERALS PROVIDING BLOOD RETURN. LEAD PREPARATION WAS PERFORMED FIRST, WITH DISSECTION DOWN TO THE BROKEN FRAGMENT OF THE OLD LEAD, WHICH TOOK A CONSIDERABLE AMOUNT OF TIME TO LOCATE. LIBERATORS WERE PLACED IN EACH LEAD AND DR. (B)(6) CHOSE NOT TO UTILIZE ONETIES FOR PROXIMAL SUPPORT. 4057 ¿ LIBERATOR LOT #N199513. 5076 ¿ LIBERATOR LOT #N199030. 4470 ¿ LIBERATOR LOT #N198962 (INITIAL). LOT #N199030 X 2 (SUBSEQUENT). THE 5076 LEAD WAS TARGETED FIRST AND EXTRACTED USING A COMBINATION OF LASER AND MECHANICAL EXTRACTION WITH A14FR EXCIMER LASER AND AN 11FR TIGHTRAIL WITH THE GOAL OF DEBULKING AND REMOVING SOME OF THE LEAD-TO-LEAD ADHESIONS PRESENT. THE 4470 WAS TARGETED NEXT WITH BOTH DEVICES AND IN THE SVC, THE LIBERATOR CAME COMPLETELY OUT OF THE LUMEN OF THE LEAD WITH THE TIP AND FIXATION FILAMENTS APPEARING TO REMAIN WITHIN THE LEAD (I HAVE THE LIBERATOR TO RETURN TO COOK FOR INVESTIGATION). A SECOND LIBERATOR WAS PLACED IN THE REMAINING LUMEN OF THE 4470, BUT NEAR SAME POINT IN THE SVC, THE LIBERATOR WENT OUTSIDE THE LUMEN OF THE LEAD AND COILED UP IN THE SVC. IT WAS REMOVED AND WE INSPECTED THE DEVICE. ALTHOUGH IT HADN¿T BEEN DEPLOYED YET, THE BEACON TIP OF THIS DEVICE WAS BENT SO WE DECIDED TO GET A NEW ONE INSTEAD OF UTILIZING THIS ONE. THE SECOND SUBSEQUENT LIBERATOR WAS PLACED AS FAR DISTAL AS POSSIBLE (INTO MID SVC) AND DEPLOYED. UPON MILD TRACTION WITH THE INTENTION TO UTILIZE AN EXTRACTION TOOL, THE LEAD FRACTURED COMPLETELY INSIDE THE VESSEL NEAR THE POINT OF FIXATION AND THE PROXIMAL PART OF THE LEAD, AND THE ENTIRE SUBSEQUENT LIBERATOR PULLED FREE, LEAVING THE TIP OF THE 4470 AND THE DISTAL PORTION OF THE BEACON TIP BEHIND. WE THEN MOVED OVER TO THE OLD 4057 LEAD FRAGMENT AND BEGAN EXTRACTING IT. IT WAS CLEAR THAT THERE WERE SIGNIFICANT LEAD TO LEAD ADHESIONS, SO WE THOUGHT WE MIGHT BE ABLE TO USE THESE TO RECOVER THE 4470 FRAGMENT. CAREFULLY USING THE EXTRACTION TOOLS TO FREE UP THE 4057 IN THE BRACHIOCEPHALIC VEIN, WE WERE ABLE TO FREE THE REST OF THE LEAD UNDER MILD TRACTION AND STILL HAD THE 4470 ATTACHED TO IT. AS THE LEAD WAS REMOVED, THE ADHESIONS TO THE 4470 RELEASED AND WE ENDED UP WITH THE LEAD FRAGMENT IN THE PREVIOUSLY OCCLUDED BRACHIOCEPHALIC VEIN. OVER THE NEXT 90 MINUTES OR SO, WE ATTEMPTED TO EXTRACT THE LEAD FRAGMENT USING MULTIPLE TECHNIQUES AND ENLISTED THE HELP OF IR DOCS. THE PATIENT STARTED BECOMING HYPOTENSIVE, SO THE DECISION WAS MADE TO ABANDON THE LEAD FRAGMENT AND PLACE A NEW SYSTEM ON THE RIGHT SIDE, WITH ONLY LEFT ATRIAL PACING AS SHE PASSED THE WENKEBACH PROTOCOL TO LIMIT THE NUMBER OF LEADS PASSING THE BAFFLE IN HER RIGHT ATRIUM. THE LEFT BRACHIOCEPHALIC IS EXPECTED TO OCCLUDE COMPLETELY AGAIN AND THE LEAD IS QUITE STABLE IN THE EXISTING CHRONIC CLOT WITH NO CONCERNS OF EMBOLIZATION. I FOLLOWED UP WITH DR.(B)(6) THIS MORNING ((B)(6) 2024) AND THE PATIENT IS DOING WELL CLINICALLY. THIS INCIDENT IS NOT EXPECTED TO BE REPORTED TO ANY REGULATORY BODY. PLEASE ALSO ADVISE IF THERE ARE ANY CONCERNS FOR MRI SAFETY WITH THE BEACON TIP OF THE LIBERATOR AND POSSIBLY THE COMPRESSION COILS REMAINING IN THE PATIENT WITHIN THE LEAD FRAGMENT. I WILL COMMUNICATE ANY POTENTIAL CONCERNS TO DR. (B)(6).
PER EMAIL RECEIVED ON 18JAN2024: SHE UNDERWENT A SURGICAL PROCEDURE AS AN INFANT KNOWN AS A MUSTARD PROCEDURE, WHICH AT THE TIME, WAS THE ACCEPTED METHOD OF CORRECTING THE BLOOD FLOW, BUT HAD THE ADDED COMPLICATION OF THE PACEMAKER LEADS BEING IN THE LEFT ATRIUM AND VENTRICLE. SHE HAD A MEDTRONIC 4057 PACEMAKER LEAD PLACED IN 1993 AT 9 YEARS OLD, WHICH CLEARLY FRACTURED AND WAS ABANDONED, REQUIRING A NEW SYSTEM IN 2005 (LA GUIDANT 4470, LV MDT 5076). RECENTLY, THE 4470 ATRIAL LEAD BEGAN MALFUNCTIONING AND BEING PACING DEPENDENT, REQUIRED ANOTHER REVISION. THE LEFT BRACHIOCEPHALIC VEIN CONTAINING THE LEADS WAS COMPLETELY OCCLUDED WITH CONSIDERABLE COLLATERALS PROVIDING BLOOD RETURN. LEAD PREPARATION WAS PERFORMED FIRST, WITH DISSECTION DOWN TO THE BROKEN FRAGMENT OF THE OLD LEAD, WHICH TOOK A CONSIDERABLE AMOUNT OF TIME TO LOCATE. LIBERATORS WERE PLACED IN EACH LEAD AND (B)(6) CHOSE NOT TO UTILIZE ONETIES FOR PROXIMAL SUPPORT. 4057 ¿ LIBERATOR LOT #N199513 5076 ¿ LIBERATOR LOT #N199030 4470 ¿ LIBERATOR LOT #N198962 (INITIAL) LOT #N199030 X 2 (SUBSEQUENT) THE 5076 LEAD WAS TARGETED FIRST AND EXTRACTED USING A COMBINATION OF LASER AND MECHANICAL EXTRACTION WITH A14FR EXCIMER LASER AND AN 11FR TIGHTRAIL WITH THE GOAL OF DEBULKING AND REMOVING SOME OF THE LEAD-TO-LEAD ADHESIONS PRESENT. THE 4470 WAS TARGETED NEXT WITH BOTH DEVICES AND IN THE SVC, THE LIBERATOR CAME COMPLETELY OUT OF THE LUMEN OF THE LEAD WITH THE TIP AND FIXATION FILAMENTS APPEARING TO REMAIN WITHIN THE LEAD (I HAVE THE LIBERATOR TO RETURN TO COOK FOR INVESTIGATION). A SECOND LIBERATOR WAS PLACED IN THE REMAINING LUMEN OF THE 4470, BUT NEAR SAME POINT IN THE SVC, THE LIBERATOR WENT OUTSIDE THE LUMEN OF THE LEAD AND COILED UP IN THE SVC. IT WAS REMOVED AND WE INSPECTED THE DEVICE. ALTHOUGH IT HADN¿T BEEN DEPLOYED YET, THE BEACON TIP OF THIS DEVICE WAS BENT SO WE DECIDED TO GET A NEW ONE INSTEAD OF UTILIZING THIS ONE. THE SECOND SUBSEQUENT LIBERATOR WAS PLACED AS FAR DISTAL AS POSSIBLE (INTO MID SVC) AND DEPLOYED. UPON MILD TRACTION WITH THE INTENTION TO UTILIZE AN EXTRACTION TOOL, THE LEAD FRACTURED COMPLETELY INSIDE THE VESSEL NEAR THE POINT OF FIXATION AND THE PROXIMAL PART OF THE LEAD, AND THE ENTIRE SUBSEQUENT LIBERATOR PULLED FREE, LEAVING THE TIP OF THE 4470 AND THE DISTAL PORTION OF THE BEACON TIP BEHIND. WE THEN MOVED OVER TO THE OLD 4057 LEAD FRAGMENT AND BEGAN EXTRACTING IT. IT WAS CLEAR THAT THERE WERE SIGNIFICANT LEAD TO LEAD ADHESIONS, SO WE THOUGHT WE MIGHT BE ABLE TO USE THESE TO RECOVER THE 4470 FRAGMENT. CAREFULLY USING THE EXTRACTION TOOLS TO FREE UP THE 4057 IN THE BRACHIOCEPHALIC VEIN, WE WERE ABLE TO FREE THE REST OF THE LEAD UNDER MILD TRACTION AND STILL HAD THE 4470 ATTACHED TO IT. AS THE LEAD WAS REMOVED, THE ADHESIONS TO THE 4470 RELEASED AND WE ENDED UP WITH THE LEAD FRAGMENT IN THE PREVIOUSLY OCCLUDED BRACHIOCEPHALIC VEIN. OVER THE NEXT 90 MINUTES OR SO, WE ATTEMPTED TO EXTRACT THE LEAD FRAGMENT USING MULTIPLE TECHNIQUES AND ENLISTED THE HELP OF IR DOCS. THE PATIENT STARTED BECOMING HYPOTENSIVE, SO THE DECISION WAS MADE TO ABANDON THE LEAD FRAGMENT AND PLACE A NEW SYSTEM ON THE RIGHT SIDE, WITH ONLY LEFT ATRIAL PACING AS SHE PASSED THE WENKEBACH PROTOCOL TO LIMIT THE NUMBER OF LEADS PASSING THE BAFFLE IN HER RIGHT ATRIUM. THE LEFT BRACHIOCEPHALIC IS EXPECTED TO OCCLUDE COMPLETELY AGAIN AND THE LEAD IS QUITE STABLE IN THE EXISTING CHRONIC CLOT WITH NO CONCERNS OF EMBOLIZATION. I FOLLOWED UP WITH (B)(6) THIS MORNING ((B)(6) 2024) AND THE PATIENT IS DOING WELL CLINICALLY. THIS INCIDENT IS NOT EXPECTED TO BE REPORTED TO ANY REGULATORY BODY. PLEASE ALSO ADVISE IF THERE ARE ANY CONCERNS FOR MRI SAFETY WITH THE BEACON TIP OF THE LIBERATOR AND POSSIBLY THE COMPRESSION COILS REMAINING IN THE PATIENT WITHIN THE LEAD FRAGMENT. I WILL COMMUNICATE ANY POTENTIAL CONCERNS TO (B)(6).
PER EMAIL RECEIVED ON 18JAN2024: SHE UNDERWENT A SURGICAL PROCEDURE AS AN INFANT KNOWN AS A MUSTARD PROCEDURE, WHICH AT THE TIME, WAS THE ACCEPTED METHOD OF CORRECTING THE BLOOD FLOW, BUT HAD THE ADDED COMPLICATION OF THE PACEMAKER LEADS BEING IN THE LEFT ATRIUM AND VENTRICLE. SHE HAD A MEDTRONIC 4057 PACEMAKER LEAD PLACED IN 1993 AT 9 YEARS OLD, WHICH CLEARLY FRACTURED AND WAS ABANDONED, REQUIRING A NEW SYSTEM IN 2005 (LA GUIDANT 4470, LV MDT 5076). RECENTLY, THE 4470 ATRIAL LEAD BEGAN MALFUNCTIONING AND BEING PACING DEPENDENT, REQUIRED ANOTHER REVISION. THE LEFT BRACHIOCEPHALIC VEIN CONTAINING THE LEADS WAS COMPLETELY OCCLUDED WITH CONSIDERABLE COLLATERALS PROVIDING BLOOD RETURN. LEAD PREPARATION WAS PERFORMED FIRST, WITH DISSECTION DOWN TO THE BROKEN FRAGMENT OF THE OLD LEAD, WHICH TOOK A CONSIDERABLE AMOUNT OF TIME TO LOCATE. LIBERATORS WERE PLACED IN EACH LEAD AND DR. (B)(6) CHOSE NOT TO UTILIZE ONETIES FOR PROXIMAL SUPPORT. 4057 ¿ LIBERATOR LOT #N199513, 5076 ¿ LIBERATOR LOT #N199030. 4470 ¿ LIBERATOR LOT #N198962 (INITIAL), LOT #N199030 X 2 (SUBSEQUENT). THE 5076 LEAD WAS TARGETED FIRST AND EXTRACTED USING A COMBINATION OF LASER AND MECHANICAL EXTRACTION WITH A14FR EXCIMER LASER AND AN 11FR TIGHTRAIL WITH THE GOAL OF DEBULKING AND REMOVING SOME OF THE LEAD-TO-LEAD ADHESIONS PRESENT. THE 4470 WAS TARGETED NEXT WITH BOTH DEVICES AND IN THE SVC, THE LIBERATOR CAME COMPLETELY OUT OF THE LUMEN OF THE LEAD WITH THE TIP AND FIXATION FILAMENTS APPEARING TO REMAIN WITHIN THE LEAD (I HAVE THE LIBERATOR TO RETURN TO COOK FOR INVESTIGATION). A SECOND LIBERATOR WAS PLACED IN THE REMAINING LUMEN OF THE 4470, BUT NEAR SAME POINT IN THE SVC, THE LIBERATOR WENT OUTSIDE THE LUMEN OF THE LEAD AND COILED UP IN THE SVC. IT WAS REMOVED AND WE INSPECTED THE DEVICE. ALTHOUGH IT HADN¿T BEEN DEPLOYED YET, THE BEACON TIP OF THIS DEVICE WAS BENT SO WE DECIDED TO GET A NEW ONE INSTEAD OF UTILIZING THIS ONE. THE SECOND SUBSEQUENT LIBERATOR WAS PLACED AS FAR DISTAL AS POSSIBLE (INTO MID SVC) AND DEPLOYED. UPON MILD TRACTION WITH THE INTENTION TO UTILIZE AN EXTRACTION TOOL, THE LEAD FRACTURED COMPLETELY INSIDE THE VESSEL NEAR THE POINT OF FIXATION AND THE PROXIMAL PART OF THE LEAD, AND THE ENTIRE SUBSEQUENT LIBERATOR PULLED FREE, LEAVING THE TIP OF THE 4470 AND THE DISTAL PORTION OF THE BEACON TIP BEHIND. WE THEN MOVED OVER TO THE OLD 4057 LEAD FRAGMENT AND BEGAN EXTRACTING IT. IT WAS CLEAR THAT THERE WERE SIGNIFICANT LEAD TO LEAD ADHESIONS, SO WE THOUGHT WE MIGHT BE ABLE TO USE THESE TO RECOVER THE 4470 FRAGMENT. CAREFULLY USING THE EXTRACTION TOOLS TO FREE UP THE 4057 IN THE BRACHIOCEPHALIC VEIN, WE WERE ABLE TO FREE THE REST OF THE LEAD UNDER MILD TRACTION AND STILL HAD THE 4470 ATTACHED TO IT. AS THE LEAD WAS REMOVED, THE ADHESIONS TO THE 4470 RELEASED AND WE ENDED UP WITH THE LEAD FRAGMENT IN THE PREVIOUSLY OCCLUDED BRACHIOCEPHALIC VEIN. OVER THE NEXT 90 MINUTES OR SO, WE ATTEMPTED TO EXTRACT THE LEAD FRAGMENT USING MULTIPLE TECHNIQUES AND ENLISTED THE HELP OF IR DOCS. THE PATIENT STARTED BECOMING HYPOTENSIVE, SO THE DECISION WAS MADE TO ABANDON THE LEAD FRAGMENT AND PLACE A NEW SYSTEM ON THE RIGHT SIDE, WITH ONLY LEFT ATRIAL PACING AS SHE PASSED THE WENKEBACH PROTOCOL TO LIMIT THE NUMBER OF LEADS PASSING THE BAFFLE IN HER RIGHT ATRIUM. THE LEFT BRACHIOCEPHALIC IS EXPECTED TO OCCLUDE COMPLETELY AGAIN AND THE LEAD IS QUITE STABLE IN THE EXISTING CHRONIC CLOT WITH NO CONCERNS OF EMBOLIZATION. I FOLLOWED UP WITH DR. (B)(6) THIS MORNING ((B)(6) 2024) AND THE PATIENT IS DOING WELL CLINICALLY. THIS INCIDENT IS NOT EXPECTED TO BE REPORTED TO ANY REGULATORY BODY. PLEASE ALSO ADVISE IF THERE ARE ANY CONCERNS FOR MRI SAFETY WITH THE BEACON TIP OF THE LIBERATOR AND POSSIBLY THE COMPRESSION COILS REMAINING IN THE PATIENT WITHIN THE LEAD FRAGMENT. I WILL COMMUNICATE ANY POTENTIAL CONCERNS TO DR. (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 206507 | LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET | DRB STYLET, CATHETER | DRB | COOK VANDERGRIFT INC | G26550 | N198962 | 10827002265506 |
| 379693 | LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET | DRB STYLET, CATHETER | DRB | COOK VANDERGRIFT INC | G26550 | N198962 | 10827002265506 |
| 952890 | LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET | DRB STYLET, CATHETER | DRB | COOK VANDERGRIFT INC | G26550 | N198962 | 10827002265506 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Female | Other |