LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
Report
- Report Number
- 2522007-2024-00035
- Event Type
- Injury
- Date Received
- September 26, 2024
- Date of Event
- September 9, 2024
- Report Date
- November 21, 2024
- Manufacturer
- COOK VANDERGRIFT INC
- Product Code
- DRE
- UDI-DI
- 10827002237473
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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. E - OCCUPATION: DOCTOR G5 ¿ PMA/510(K): 141148 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.
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. THE LOT FOR THIS DEVICE IS KNOW. G5 ¿ PMA/510(K): K141148. 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: "LEAD SEVERED." 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.
A PHILIPS LLD #2 (LEAD LOCKING DEVICE) WAS INSERTED INTO THE STYLET LUMEN OF THE ICD LEAD AND ADVANCED TO THE TIP. 14FR GLIDELIGHT WAS INSERTED THROUGH THE PUNCTURE SITE AND DISSECTION/SEPARATION OF THE ICD LEAD WAS STARTED, BUT IT STOPPED IN THE MIDDLE OF SUBCLAVIAN VEIN. THEREFORE, THE DEVICE WAS CHANGED TO AN EVOLUTION SHORTIE RL 11FR, WHICH ALLOWED IT TO PASS THROUGH THE SUBCLAVIAN VEIN. NEXT, THE DEVICE WAS CHANGED TO AN EVOLUTION RL 11FR, AND WHILE DISSECTING JUST BEFORE THE SVC (SUPERIOR VENA CAVA), THE TIP OF THE LEAD SEEMED TO HAVE COME OFF, BUT IN FACT IT HAD NOT COME OFF, SO THE DEVICE WAS TRIED TO PROCEED WITH DISSECTION AGAIN WITH AN 11FR, BUT THE MIDDLE OF THE SVC COIL (WHERE THERE MAY BE A MASS OF ADHESION TISSUE) DID NOT ENTER THE SHEATH. THEREFORE, THE DEVICE WAS CHANGED TO AN EVOLUTION RL 13FR, BUT THE SAME PART DID NOT ENTER THE SHEATH, SO THE DEVICE WAS CHANGED TO A GLIDELIGHT 16FR, BUT THE SAME PART DID NOT ENTER THE SHEATH. WHEN A 13FR STEADY SHEATH WAS SET INSIDE THE EVOLUTION RL 13FR AND ADVANCED, THE INNER SHEATH OF THE EVOLUTION RL 13FR DID NOT PASS THE MIDDLE OF THE SVC COIL WHERE THERE MAY BE A MASS OF ADHESION TISSUE, BUT THE STEADY SHEATH PASSED THROUGH. HOWEVER, IF THE STEADY SHEATH ALONE WAS USED TO CONTINUE THE DISSECTION WHEN THE INNER SHEATH WAS NOT KEEPING UP (NOT ADVANCING/RUNNING PARALLEL), THE STEADY SHEATH WOULD KINK, SO THE USER STOPPED CONTINUING THE DISSECTION WITH THIS SYSTEM. WHEN WE CHANGED TO THE OUTER SHEATH OF THE 13.0FR BYRD DILATOR SHEATH SET, IT PASSED THE MIDDLE OF THE SVC COIL AND THE DISSECTION PROCEEDED TO THE SVC. AFTER THIS, WE CHANGED TO AN EVOLUTION RL 13FR + STEADY SHEATH, HOPING THAT EVOLUTION WOULD ALSO PASS, BUT IT DID NOT PASS THE MIDDLE OF THE SVC COIL. THEREFORE, AN ABBOTT¿S AGILIS NXT INTRODUCER WAS INSERTED THROUGH THE PERFORMER CHECK FLOW INTRODUCER SET 18FR 40CM (HEREAFTER REFERRED TO AS CHECK FLOW 18FR) THAT HAD BEEN INSERTED INTO THE RIGHT FEMORAL VEIN, AND AN LR-NES001 WAS INSERTED INTO IT, AND THE EVOLUTION RL 13FR + STEADY SHEATH WAS ADVANCED WHILE GRASPING AND PULLING THE ICD LEAD DOWNWARD BYLR-NES001, AND IT PASSED THROUGH THE SVC COIL. AS THE DISSECTION PROGRESSED TO THE POINT GRASPED BY THE LR-NES001, THE LR-NES001 WAS RELEASED AND AN EVOLUTION RL 13FR + STEADY SHEATH WAS ADVANCED IN AN ATTEMPT TO DISSECT THE REMAINING PART, BUT WHILE DISSECTING THE PROXIMAL PART OF THE RV COIL, THE ICD LEAD SEVERED, LEAVING ONLY THE RV COIL AND THE CABLE PROXIMAL TO IT. THE PROXIMAL PART OF THE LEAD OTHER THAN THAT WAS ABLE TO BE RETRIEVED AT THAT TIME. THE RV COIL WAS GRASPED WITH AN AGILIS NXT INTRODUCER + MERITMEDICAL'S EN SNARE FROM A CHECKFLOW 18FR, AND THE MIDDLE OF THE RV COIL WAS GRASPED WITH AN OSYPKA'S SNARE AND PULLED INTO THE CHECKFLOW 18FR. THE USER HOPED THAT THE FORCE OF TRACTION WOULD DETACH THE TIP AND ALLOW EVERYTHING TO BE RETRIEVED, BUT THE SNARE CAME OFF, SO HE RE-GRABBED THE LEAD WITH AN OSYPKA'S SNARE AND PULLED IT AGAIN INTO THE CHECKFLOW 18FR, BUT IT DID NOT ENTER THE SHEATH AND THE LEAD BROKE AGAIN, CAUSING THE RV COIL TO BECOME ABOUT HALF ITS ORIGINAL LENGTH. THEREFORE, HE PLACED A GLIDELIGHT 16FR INTO THE CHECKFLOW 18FR, INSERTED AN AGILIS NXT INTRODUCER INTO IT, INSERTED AN LR-NES001 INTO IT, AND TRIED TO GRAB THE REMAINING CABLE, BUT FAILED. HE REPLACED THE LR-NES001 WITH MERITMEDICAL'S EN SNARE, WHICH WAS ABLE TO GRIP THE CABLE, AND HE IRRADIATED THE EXCIMER LASER WHILE PULLING THE CABLE INTO THE 18FR CHECKFLOW WITHOUT REMOVING THE CABLE. DURING SEVERAL IRRADIATIONS, THE SNARE WAS UNCLAMPED, AND THE MOMENTUM OF THE UNCLAMPING CAUSED THE GLIDELIGHT 16FR TO RISE VIGOROUSLY TO THE UPPER RIGHT ATRIUM, AND IMMEDIATELY AFTER THAT, THE BLOOD PRESSURE DROPPED TO THE 30'S. THE ANESTHESIOLOGIST EXAMINED THE PATIENT WITH A TRANSESOPHAGEAL ECHOCARDIOGRAM, WHICH REVEALED PERICARDIAL FLUID ACCUMULATION, AND DIAGNOSED CARDIAC TAMPONADE. PERICARDIAL DRAINAGE WAS CONTINUED, BUT THE BLOOD PRESSURE DID NOT RETURN TO NORMAL, SO THE PATIENT WAS CONNECTED TO PCPS. THEN A CARDIOVASCULAR SURGEON INTERVENED, PERFORMED A MEDIAN STERNOTOMY, REPAIRED THE DAMAGED AREA IN THE IVC THAT WAS DETERMINED TO BE CAUSED BY THE EXCIMER LASER IRRADIATION BY THE USER, AND BY THE TIME THE WOUND WAS CLOSED, THE BLOOD PRESSURE HAD RECOVERED TO 86/50 AND THE PROCEDURE WAS COMPLETED. PHYSICIAN COMMENTED AS BELOW: THE IVC WAS DAMAGED BY THE EXCIMER LASER IRRADIATION. THE LASER SHOULD NOT HAVE BEEN APPLIED AT THAT LOCATION. THE IVC DAMAGE WAS NOT CAUSED BY THE COOK PRODUCT.
A PHILIPS LLD #2 (LEAD LOCKING DEVICE) WAS INSERTED INTO THE STYLET LUMEN OF THE ICD LEAD AND ADVANCED TO THE TIP. 14FR GLIDELIGHT WAS INSERTED THROUGH THE PUNCTURE SITE AND DISSECTION/SEPARATION OF THE ICD LEAD WAS STARTED, BUT IT STOPPED IN THE MIDDLE OF SUBCLAVIAN VEIN. THEREFORE, THE DEVICE WAS CHANGED TO AN EVOLUTION SHORTIE RL 11FR, WHICH ALLOWED IT TO PASS THROUGH THE SUBCLAVIAN VEIN. NEXT, THE DEVICE WAS CHANGED TO AN EVOLUTION RL 11FR, AND WHILE DISSECTING JUST BEFORE THE SVC (SUPERIOR VENA CAVA), THE TIP OF THE LEAD SEEMED TO HAVE COME OFF, BUT IN FACT IT HAD NOT COME OFF, SO THE DEVICE WAS TRIED TO PROCEED WITH DISSECTION AGAIN WITH AN 11FR, BUT THE MIDDLE OF THE SVC COIL (WHERE THERE MAY BE A MASS OF ADHESION TISSUE) DID NOT ENTER THE SHEATH. THEREFORE, THE DEVICE WAS CHANGED TO AN EVOLUTION RL 13FR, BUT THE SAME PART DID NOT ENTER THE SHEATH, SO THE DEVICE WAS CHANGED TO A GLIDELIGHT 16FR, BUT THE SAME PART DID NOT ENTER THE SHEATH. WHEN A 13FR STEADY SHEATH WAS SET INSIDE THE EVOLUTION RL 13FR AND ADVANCED, THE INNER SHEATH OF THE EVOLUTION RL 13FR DID NOT PASS THE MIDDLE OF THE SVC COIL WHERE THERE MAY BE A MASS OF ADHESION TISSUE, BUT THE STEADY SHEATH PASSED THROUGH. HOWEVER, IF THE STEADY SHEATH ALONE WAS USED TO CONTINUE THE DISSECTION WHEN THE INNER SHEATH WAS NOT KEEPING UP (NOT ADVANCING/RUNNING PARALLEL), THE STEADY SHEATH WOULD KINK, SO THE USER STOPPED CONTINUING THE DISSECTION WITH THIS SYSTEM. WHEN WE CHANGED TO THE OUTER SHEATH OF THE 13.0FR BYRD DILATOR SHEATH SET, IT PASSED THE MIDDLE OF THE SVC COIL AND THE DISSECTION PROCEEDED TO THE SVC. AFTER THIS, WE CHANGED TO AN EVOLUTION RL 13FR + STEADY SHEATH, HOPING THAT EVOLUTION WOULD ALSO PASS, BUT IT DID NOT PASS THE MIDDLE OF THE SVC COIL. THEREFORE, AN ABBOTT¿S AGILIS NXT INTRODUCER WAS INSERTED THROUGH THE PERFORMER CHECK FLOW INTRODUCER SET 18FR 40CM (HEREAFTER REFERRED TO AS CHECK FLOW 18FR) THAT HAD BEEN INSERTED INTO THE RIGHT FEMORAL VEIN, AND AN LR-NES001 WAS INSERTED INTO IT, AND THE EVOLUTION RL 13FR + STEADY SHEATH WAS ADVANCED WHILE GRASPING AND PULLING THE ICD LEAD DOWNWARD BYLR-NES001, AND IT PASSED THROUGH THE SVC COIL. AS THE DISSECTION PROGRESSED TO THE POINT GRASPED BY THE LR-NES001, THE LR-NES001 WAS RELEASED AND AN EVOLUTION RL 13FR + STEADY SHEATH WAS ADVANCED IN AN ATTEMPT TO DISSECT THE REMAINING PART, BUT WHILE DISSECTING THE PROXIMAL PART OF THE RV COIL, THE ICD LEAD SEVERED, LEAVING ONLY THE RV COIL AND THE CABLE PROXIMAL TO IT. THE PROXIMAL PART OF THE LEAD OTHER THAN THAT WAS ABLE TO BE RETRIEVED AT THAT TIME. THE RV COIL WAS GRASPED WITH AN AGILIS NXT INTRODUCER + MERITMEDICAL'S EN SNARE FROM A CHECKFLOW 18FR, AND THE MIDDLE OF THE RV COIL WAS GRASPED WITH AN OSYPKA'S SNARE AND PULLED INTO THE CHECKFLOW 18FR. THE USER HOPED THAT THE FORCE OF TRACTION WOULD DETACH THE TIP AND ALLOW EVERYTHING TO BE RETRIEVED, BUT THE SNARE CAME OFF, SO HE RE-GRABBED THE LEAD WITH AN OSYPKA'S SNARE AND PULLED IT AGAIN INTO THE CHECKFLOW 18FR, BUT IT DID NOT ENTER THE SHEATH AND THE LEAD BROKE AGAIN, CAUSING THE RV COIL TO BECOME ABOUT HALF ITS ORIGINAL LENGTH. THEREFORE, HE PLACED A GLIDELIGHT 16FR INTO THE CHECKFLOW 18FR, INSERTED AN AGILIS NXT INTRODUCER INTO IT, INSERTED AN LR-NES001 INTO IT, AND TRIED TO GRAB THE REMAINING CABLE, BUT FAILED. HE REPLACED THE LR-NES001 WITH MERITMEDICAL'S EN SNARE, WHICH WAS ABLE TO GRIP THE CABLE, AND HE IRRADIATED THE EXCIMER LASER WHILE PULLING THE CABLE INTO THE 18FR CHECKFLOW WITHOUT REMOVING THE CABLE. DURING SEVERAL IRRADIATIONS, THE SNARE WAS UNCLAMPED, AND THE MOMENTUM OF THE UNCLAMPING CAUSED THE GLIDELIGHT 16FR TO RISE VIGOROUSLY TO THE UPPER RIGHT ATRIUM, AND IMMEDIATELY AFTER THAT, THE BLOOD PRESSURE DROPPED TO THE 30'S. THE ANESTHESIOLOGIST EXAMINED THE PATIENT WITH A TRANSESOPHAGEAL ECHOCARDIOGRAM, WHICH REVEALED PERICARDIAL FLUID ACCUMULATION, AND DIAGNOSED CARDIAC TAMPONADE. PERICARDIAL DRAINAGE WAS CONTINUED, BUT THE BLOOD PRESSURE DID NOT RETURN TO NORMAL, SO THE PATIENT WAS CONNECTED TO PCPS. THEN A CARDIOVASCULAR SURGEON INTERVENED, PERFORMED A MEDIAN STERNOTOMY, REPAIRED THE DAMAGED AREA IN THE IVC THAT WAS DETERMINED TO BE CAUSED BY THE EXCIMER LASER IRRADIATION BY THE USER, AND BY THE TIME THE WOUND WAS CLOSED, THE BLOOD PRESSURE HAD RECOVERED TO 86/50 AND THE PROCEDURE WAS COMPLETED. PHYSICIAN COMMENTED AS BELOW: THE IVC WAS DAMAGED BY THE EXCIMER LASER IRRADIATION. THE LASER SHOULD NOT HAVE BEEN APPLIED AT THAT LOCATION. THE IVC DAMAGE WAS NOT CAUSED BY THE COOK PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1244409 | LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET | DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHERIZATION | DRE | COOK VANDERGRIFT INC | G23747 | N197583 | 10827002237473 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Male | Other | 14FR GLIDELIGHT.| ABBOTT¿S AGILIS NXT INTRODUCER.| GLIDELIGHT 16FR.| LR-EVN-11.0-RL.| LR-EVN-SH-11.0-RL.| LR-NES001.| LR-PPLBES-13.0.| LR-TSS-13.0.| MERITMEDICAL'S EN SNARE.| OSYPKA'S SNARE.| PERFORMER CHECK FLOW INTRODUCER SET 18FR 40CM.| PHILIPS LLD #2. |