LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION
Report
- Report Number
- 2522007-2020-00004
- Event Type
- Injury
- Date Received
- January 7, 2020
- Report Date
- October 19, 2020
- Manufacturer
- COOK VANDERGRIFT INC
- Product Code
- DXE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
ADDITIONAL INFORMATION: H6- EC METHOD CODE DESC - 1: DEVICE NOT RETURNED (4114). H6- EC RESULTS CODE DESC - 1: CHANGED TO NO FINDINGS AVAILABLE (3221). H6- EC CONCLUSIONS CODE DESC - 1: CHANGED TO KNOWN INHERENT RISK OF DEVICE (22). H10- ADDED SUMMARY OF INVESTIGATION. INVESTIGATION-EVALUATION: NO LR-NES DEVICES WERE RETURNED TO CVI, THEREFORE A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. THE COMPLAINT / EVENT THAT WAS ENTERED INTO TRACKWISE: (B)(4), PATIENT#: 2 OF 9, MAJOR COMPLICATIONS POST PROCEDURE AND FULL RECOVERED". AS REPORTED IN LITERATURE FINDING, "THE MEDICAL RECORDS OF PATIENTS WHO UNDERWENT TLE (TRANVENOUS LEAD EXTRACTION PROCEDURES) VIA THE FEMORAL APPROACH UTILIZING THE NES FROM MAY 2014 TO JUNE 2019 IN PEKING UNIVERSITY PEOPLE¿S HOSPITAL WERE RETROSPECTIVELY REVIEWED. MAJOR COMPLICATIONS INCLUDING DEATH OCCURRED IN NINE PATIENTS (1.9%), OF WHOM EIGHT DEVELOPED CARDIAC TAMPONADE. AMONG THESE EIGHT PATIENTS EMERGENCY PERICARDIOCENTESIS FOLLOWED BY RESCUE SURGICAL REPAIR IF NECESSARY WAS SUCCESSFUL IN 6 (75.0% AND FAILED IN 2 (25.0%).¿ THIS REPORT IS INTENDED TO CAPTURE PATIENT #2 OF THE 9 SITED IN THIS EXCERPT. WHILE UNDERGOING A TRANSVENOUS LEAD EXTRACTION PROCEDURES USING THE COOK NEEDLE¿S EYE SNARE (LR-NES002), PATIENT #2 EXPERIENCES A CARDIAC TAMPONADE WHICH REQUIRED PERICARDIOCENTESIS AND SURGICAL REPAIR. THE LITERATURE FINING INDICATES THAT THE PATIENT FULLY RECOVERED FROM THIS EVENT. ADDITIONAL REPORTS WILL BE FILED TO CAPTURE EACH REMAINING PATIENT ADVERSE EVENTS SITED IN THIS ARTICLE. THE QUALITY ASSURANCE DEPARTMENT REVIEWED THE PROVIDED ARTICLE. THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED DUE TO THE UNKNOWN LOT. A MANUFACTURING FAILURE/DEFECT OF THE DEVICE COULD NOT BE CONFIRMED WITH THE INFORMATION PROVIDED. ADVERSE PHYSIOLOGICAL RESPONSE IS A KNOW FAILURE MODE OF THIS DEVICE. THIS COMPLAINT WILL BE MONITORED AND TRENDED THROUGH THE CVI COMPLAINT HANDLING AND THE POST MARKET SURVEILLANCE PROCESSES. A RISK ASSESSMENT WILL BE PERFORMED VIA QERA 200617.1 AND DOCUMENTED IN THE COMPLAINT SUMMARY OF TRACKWISE. PER IFU (D00078684 REV 002): "POTENTIAL ADVERSE EVENTS: DISLODGING OR DAMAGING NONTARGETED CATHETER/LEAD, CHEST WALL HEMATOMA, THROMBOSIS, ARRHYTHMIAS, ACUTE BACTEREMIA, ACUTE HYPOTENSION, PNEUMOTHORAX, STROKE, MIGRATING FRAGMENT FROM CATHETER / OBJECT, PULMONARY EMBOLISM, LACERATION OR TEARING OF VASCULAR STRUCTURES OR THE MYOCARDIUM, HEMOPERICARDIUM / PERICARDIAL EFFUSION, CARDIAC TAMPONADE, HEMOTHORAX, CARDIAC ARREST, DEATH." 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.
AS REPORTED IN LITERATURE FINDING, "THE MEDICAL RECORDS OF PATIENTS WHO UNDERWENT TLE (TRANVENOUS LEAD EXTRACTION PROCEDURES) VIA THE FEMORAL APPROACH UTILIZING THE NES FROM MAY 2014 TO JUNE 2019 IN PEKING UNIVERSITY PEOPLE¿S HOSPITAL WERE RETROSPECTIVELY REVIEWED. MAJOR COMPLICATIONS INCLUDING DEATH OCCURRED IN NINE PATIENTS (1.9%), OF WHOM EIGHT DEVELOPED CARDIAC TAMPONADE. AMONG THESE EIGHT PATIENTS EMERGENCY PERICARDIOCENTESIS FOLLOWED BY RESCUE SURGICAL REPAIR IF NECESSARY WAS SUCCESSFUL IN 6 (75.0% AND FAILED IN 2 (25.0%).¿ THIS REPORT IS INTENDED TO CAPTURE PATIENT #2 OF THE 9 SITED IN THIS EXCERPT. WHILE UNDERGOING A TRANSVENOUS LEAD EXTRACTION PROCEDURES USING THE COOK NEEDLE¿S EYE SNARE (LR-NES002), PATIENT #2 EXPERIENCES A CARDIAC TAMPONADE WHICH REQUIRED PERICARDIOCENTESIS AND SURGICAL REPAIR. THE LITERATURE FINING INDICATES THAT THE PATIENT FULLY RECOVERED FROM THIS EVENT. ADDITIONAL REPORTS WILL BE FILED TO CAPTURE EACH REMAINING PATIENT ADVERSE EVENTS SITED IN THIS ARTICLE.
PRODUCT CODE: DXE. PMA/510(K): K961992. (B)(4). 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. (B)(4).
AS REPORTED IN LITERATURE FINDING, "THE MEDICAL RECORDS OF PATIENTS WHO UNDERWENT TLE (TRANSVENOUS LEAD EXTRACTION PROCEDURES) VIA THE FEMORAL APPROACH UTILIZING THE NES FROM MAY 2014 TO JUNE 2019 IN PEKING UNIVERSITY PEOPLE¿S HOSPITAL WERE RETROSPECTIVELY REVIEWED. MAJOR COMPLICATIONS INCLUDING DEATH OCCURRED IN NINE PATIENTS (1.9%), OF WHOM EIGHT DEVELOPED CARDIAC TAMPONADE. AMONG THESE EIGHT PATIENTS EMERGENCY PERICARDIOCENTESIS FOLLOWED BY RESCUE SURGICAL REPAIR IF NECESSARY WAS SUCCESSFUL IN 6 (75.0% AND FAILED IN 2 (25.0%).¿ THIS REPORT IS INTENDED TO CAPTURE PATIENT #2 OF THE 9 SITED IN THIS EXCERPT. WHILE UNDERGOING A TRANSVENOUS LEAD EXTRACTION PROCEDURES USING THE COOK NEEDLE¿S EYE SNARE (LR-NES002), PATIENT #2 EXPERIENCES A CARDIAC TAMPONADE WHICH REQUIRED PERICARDIOCENTESIS AND SURGICAL REPAIR. THE LITERATURE FINING INDICATES THAT THE PATIENT FULLY RECOVERED FROM THIS EVENT. ADDITIONAL REPORTS WILL BE FILED TO CAPTURE EACH REMAINING PATIENT ADVERSE EVENTS SITED IN THIS ARTICLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 21887 | LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION | DXE CATHETER, EMBOLECTOMY | DXE | COOK VANDERGRIFT INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Required Intervention |