LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
Report
- Report Number
- 2522007-2022-00022
- Event Type
- Injury
- Date Received
- October 25, 2022
- Report Date
- January 3, 2023
- Manufacturer
- COOK VANDERGRIFT INC
- Product Code
- DRE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PROCODE: DRE. 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.
D2B ¿ PRODUCT CODE: DRE. G5 ¿ PMA/510(K): K141148. A DEVICE WAS NOT RETURNED ON THIS COMPLAINT, THEREFORE A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED AND THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED OTHER THAN BY CUSTOMER'S TESTIMONY. THE COMPLAINT/EVENT THAT WAS ENTERED AND REPORTED INTO TRACKWISE: "ONE PATIENT DEVELOPED LATE PERICARDIAL TAMPONADE, PNEUMOTHORAX, AND PERIPHERAL THROMBOEMBOLISM." PER THE JOURNAL ARTICLE: STEP BY STEP THROUGH THE YEARS¿HIGH VS. LOW ENERGY LEAD EXTRACTION USING ADVANCED EXTRACTION TECHNIQUES: "POST-PROCEDURAL COMPLICATIONS WERE SEEN IN 1.9% OF PROCEDURES, INCLUDING HEMATOMA REQUIRING DRAINAGE OR REINTERVENTION (0.6%), REVISION OF THE POCKET DUE TO OTHER REASONS (0.4%). TWO PATIENTS (0.3%) DEVELOPED SEVERE TRICUSPID REGURGITATION, ONE PATIENT EACH DEVELOPED LATE PERICARDIAL TAMPONADE, PNEUMOTHORAX AND PERIPHERAL THROMBOEMBOLISM. ONE PATIENT DIED WITHIN 24 H AFTER THE PROCEDURE. THERE WERE NO DIFFERENCES IN THE RATE OF COMPLICATIONS OR DEATH AFTER THE PROCEDURE IN ICD VS. NON-ICD GROUPS." THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED DUE TO THE LOT WAS UNKNOWN SPECIFIC TO THIS COMPLAINT. 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 PER COMPLAINT FORM: THERE WERE NO DIFFERENCES IN THE RATE OF COMPLICATIONS OR DEATH AFTER THE PROCEDURE IN ICD VS. NON-ICD GROUPS. TWO PATIENTS DEVELOPED SEVERE TRICUSPID REGURGITATION, ONE PATIENT DEVELOPED LATE PERICARDIAL TAMPONADE, PNEUMOTHORAX, AND PERIPHERAL THROMBOEMBOLISM.
AS PER COMPLAINT FORM: THERE WERE NO DIFFERENCES IN THE RATE OF COMPLICATIONS OR DEATH AFTER THE PROCEDURE IN ICD VS. NON-ICD GROUPS. TWO PATIENTS DEVELOPED SEVERE TRICUSPID REGURGITATION, ONE PATIENT DEVELOPED LATE PERICARDIAL TAMPONADE, PNEUMOTHORAX, AND PERIPHERAL THROMBOEMBOLISM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2721666 | LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET | VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION | DRE | COOK VANDERGRIFT INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other | BYRD DILATOR - COOK| BYRD DILATOR - COOK| LLD - SPECTRANETICS| LLD - SPECTRANETICS| SLS II LASER SHEATH - SPECTRANETICS| SLS II LASER SHEATH - SPECTRANETICS| TIGHTRAIL - SPECTRANETICS| TIGHTRAIL - SPECTRANETICS |