LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
Report
- Report Number
- 2522007-2024-00037
- Event Type
- Injury
- Date Received
- September 30, 2024
- Date of Event
- September 24, 2024
- Report Date
- November 20, 2024
- Manufacturer
- COOK VANDERGRIFT INC
- Product Code
- DRE
- UDI-DI
- 10827002237466
- 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 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 OF THE DEVICE WAS KNOWN. E1- CUSTOMER (PERSON): (B)(6) DR. 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: "AFTER THE SURGERY THE USER SAID THAT THE BLOOD COULD HAVE COME FROM THE VENA AND COULD HAVE BEEN CAUSED BY OUR PRODUCT." 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.
BLANK FIELDS ON THIS FORM INDICATED THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. 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. E3 - OCCUPATION: DOCTOR. G5 ¿ PMA/510(K): K141148. 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.
AFTER THE PROCEDURE, THE PATIENT HAD TO UNDERGO SURGERY BECAUSE OF A BLOOD HEMORRHAGE. AFTER THE SURGERY THE USER SAID THAT THE BLOOD COULD HAVE COME FROM THE VENA AND COULD HAVE BEEN CAUSED BY OUR PRODUCT. ONCE EXTRACTED ATRIAL PACEMAKER WITHOUT ANY PROBLEM DURING FIBROLISIS WITH EVOLUTION 11.0 LONG SHAFT, IT OCCURRED HEMORRHAGE (PERICARDIAL TAMPONADE). AFTER PERICARDIOCENTESIS, PATIENT HAS BEEN TRANSFERRED IN OPERATING ROOM TO CARDIAC SURGEONS THAT FOUND A SEVERE DAMAGE ON SUPERIOR VENA CAVA THAT THEY REPAIRED.
AFTER THE PROCEDURE, THE PATIENT HAD TO UNDERGO SURGERY BECAUSE OF A BLOOD HEMORRHAGE. AFTER THE SURGERY THE USER SAID THAT THE BLOOD COULD HAVE COME FROM THE VENA AND COULD HAVE BEEN CAUSED BY OUR PRODUCT. ONCE EXTRACTED ATRIAL PACEMAKER WITHOUT ANY PROBLEM DURING FIBROLISIS WITH EVOLUTION 11.0 LONG SHAFT, IT OCCURRED HEMORRHAGE (PERICARDIAL TAMPONADE). AFTER PERICARDIOCENTESIS, PATIENT HAS BEEN TRANSFERRED IN OPERATING ROOM TO CARDIAC SURGEONS THAT FOUND A SEVERE DAMAGE ON SUPERIOR VENA CAVA THAT THEY REPAIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30427 | LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET | DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHERIZATION | DRE | COOK VANDERGRIFT INC | G23746 | N203943 | 10827002237466 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Female | Other | LR-EVN-SH-11.0-RL| LR-EVN-SH-11.0-RL| LR-OFA01| LR-OFA01| LR-OTE-N| LR-OTE-N| LR-TSS-11.0| LR-TSS-11.0| LR-TSS-SH-11.0| LR-TSS-SH-11.0 |