LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
Report
- Report Number
- 2522007-2022-00008
- Event Type
- Injury
- Date Received
- March 9, 2022
- Date of Event
- February 9, 2022
- Report Date
- May 5, 2022
- Manufacturer
- COOK VANDERGRIFT INC
- Product Code
- DRE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PRODUCT CODE: DRE. PMA/510(K): K141148. 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.
D2B: PRODUCT CODE: DRE. G4: PMA/510(K): K141148. THE DEVICE WAS NOT RETURNED ON THIS COMPLAINT, THEREFORE A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED AND THE CUSTOMER'S TESTIMONY/LITERATURE IS THE CONFIRMATION OF THE COMPLAINT. THE COMPLAINT ENTERED WITHIN TRACKWISE: "THE PATIENT BECAME HEMODYNAMIC UNSTABLE AND PERICARDIAL EFFUSION WAS DRAINED PERCUTANEOUSLY." PER LITERATURE: "A 57-YEAR-OLD WOMAN WITH A DUAL-CHAMBER ICD WHO HAD EXTERNALIZATION OF HER RIATA 1580 DUAL-COIL IN SITU SHOCK LEAD WHICH WAS FOR 8 YEARS. AN EVOLUTION RL SHEATH WAS USED TO FREE THE LEAD UP TO THE TRICUSPID ANNULUS. AFTER THIS MANEUVER, THE PATIENT BECAME HEMODYNAMIC UNSTABLE AND PERICARDIAL EFFUSION WAS DRAINED PERCUTANEOUSLY. AFTER COMPLETE REMOVAL OF THE ICD LEAD USING THE FEMORAL SNARE, THE PATIENT DETERIORATED DESPITE THE DRAIN AND AN EMERGENT STERNOTOMY WAS PERFORMED DEMONSTRATING LACERATION OF THE RIGHT ATRIAL WALL." THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED DUE TO THE LOT USED WITHIN THIS COMPLAINT WAS UNKNOWN. THIS COMPLAINT WILL BE MONITORED, TRACKED, AND TRENDED PER CVI'S POST MARKET SURVEILLANCE AND COMPLAINT HANDLING PROCESSES. A RISK ASSESSMENT WILL BE PERFORMED AND DOCUMENTED PER THE COMPLAINT SUMMARY TAB WITHIN 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.
THIS LITERATURE FINDING SPECIFIES TWO MAJOR ADVERSE EVENTS ATTRIBUTED TO THE COOK EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET DURING A TRANSVENOUS LEAD EXTRACTION (TLE): A (B)(6) WOMAN UNDERWENT A TLE PROCEDURE FOR EXTERNALIZATION OF A RIATA 1580 DUAL-COIL SHOCK LEAD THAT WAS IN PLACE FOR 8 YEARS. A COOK EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET WAS USED TO FREE THE LEAD TIP TO THE TRICUSPID ANNULUS. THEN, THE PATIENT BECAME HEMODYNAMIC UNSTABLE AND PERICARDIAL EFFUSION WAS DRAINED PERCUTANEOUSLY. AFTER COMPLETE REMOVAL OF THE ICD LEAD USING THE COOK NEEDLE'S EYE SNARE, THE PATIENT DETERIORATED DESPITE THE DRAIN SO AN EMERGENT STERNOTOMY WAS PERFORMED WHICH SHOWED A LACERATION OF THE RIGHT ATRIAL WALL. SHE RECOVERED CLINICALLY AND WAS DOING WELL AT HER 5 YEAR FOLLOW-UP. A (B)(6) MAN WITH A BIVENTRICULAR ICD HAD ATRIAL AND LEFT VENTRICULAR LEAD MALFUNCTION. THE PATIENT EXPERIENCED WEDGING OF A DISTAL PART OF A BIOTRONIK SETROX S53 ATRIAL LEAD IN THE SUBCLAVIAN VEIN. THE COOK EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET CAUSED EXCESSIVE BLEEDING AT THE VENOUS ENTRY SITE THAT REQUIRED SURGICAL REPAIR. PHYSICIANS DECIDED TO LEAVE REMNANT LEAD IN PLACE.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1574249 | LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET | DRE | COOK VANDERGRIFT INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |