DYB INTRODUCER, CATHETER
Report
- Report Number
- 1820334-2024-01162
- Event Type
- Injury
- Date Received
- September 4, 2024
- Date of Event
- August 7, 2024
- Report Date
- December 6, 2024
- Manufacturer
- COOK INC
- Product Code
- DYB
- PMA / PMN Number
- K171275
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
SUMMARY OF EVENT: AS REPORTED, DURING A PROCEDURE INVOLVING ENDOVASCULAR REPAIR OF AN AORTIC ANEURYSM, AN UNSPECIFIED MICROPUNCTURE INTRODUCER SET'S SHEATH SEPARATED. REPORTEDLY, THE SHEATH WAS RETAINED IN THE PATIENT. AFTER RETRIEVAL IT WAS NOTED THAT ONE END OF THE SHEATH APPEARED "SHEARED". AN UNSPECIFIED ADDITIONAL INTERVENTION WAS PERFORMED. ADDITIONAL INFORMATION WAS RECEIVED 10SEP2024. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY. PER THE REPORTER, AFTER THE SHEATH WAS INSERTED INTO THE PATIENT, THE SURGEON USED A ¿KNIFE¿ TO CUT THE SKIN ¿A LITTLE BIT¿. REPORTEDLY, WHEN THE SURGEON PULLED THE SHEATH OUT, APPROXIMATELY EIGHT CENTIMETERS OF THE SHEATH HAD SEPARATED AND WAS MISSING. A VERY SMALL AMOUNT, APPROXIMATELY TWO CENTIMETERS, OF SHEATH ¿POSSIBLY¿ REMAINED IN THE HUB. IT IS UNKNOWN IF THE ACCESS SITE WAS SCARRED OR CALCIFIED, OR IF RESISTANCE WAS ENCOUNTERED DURING INSERTION OF THE DEVICE; HOWEVER, PER THE REPORTER, BECAUSE THE SURGEON USED A ¿KNIFE¿ TO CUT THE SKIN, SLIGHT RESISTANCE IS ASSUMED. THE DEVICE WAS NOT ADVANCED OR REMOVED THROUGH A PREVIOUSLY PLACED CLOSURE DEVICE. THE ORIGINAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS INITIALLY SENT TO THE RECOVERY ROOM WITH THE SEPARATED SHEATH FRAGMENT IN THE BODY; HOWEVER, THE PATIENT WENT BACK TO THE OPERATING ROOM FOR REMOVAL OF THE FRAGMENT VIA SURGICAL CUT DOWN. THE FRAGMENT, WHICH WAS FOUND IN THE POPLITEAL ARTERY, WAS SUCCESSFULLY REMOVED, AND NOTHING REMAINED IN THE PATIENT. INVESTIGATION EVALUATION: REVIEWS OF THE INSTRUCTIONS FOR USE (IFU), DOCUMENTATION, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED TO COOK, AND A SEARCH OF SALES HISTORY COULD NOT DETERMINE THE LOT; THEREFORE, THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE REVIEWED. THE PRODUCT IFU STATES ¿DO NOT ATTEMPT TO INSERT OR WITHDRAW THE WIRE GUIDE AND/OR INTRODUCER IF RESISTANCE IS FELT¿. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR AND IFU SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT PROCEDURAL ISSUES CONTRIBUTED TO THIS EVENT, AS THE USER REPORTED THAT THE ACCESS SITE WAS CUT WHILE THE SHEATH WAS IN PLACE. IT IS POSSIBLE THAT THE SHEATH WAS DAMAGED WHEN THE ACCESS SITE WAS CUT, LEADING TO SHAFT SEPARATION APPROXIMATELY TWO CENTIMETERS FROM THE HUB. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ADDITIONAL ESCALATION WAS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
ADDITIONAL INFORMATION: B5. ADDITIONAL/CORRECTED INFORMATION: B2, H6 (ANNEXES E & F). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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 REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
ADDITIONAL INFORMATION WAS RECEIVED 10SEP2024. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY. PER THE REPORTER, AFTER THE SHEATH WAS INSERTED INTO THE PATIENT, THE SURGEON USED A ¿KNIFE¿ TO CUT THE SKIN ¿A LITTLE BIT¿. REPORTEDLY, WHEN THE SURGEON PULLED THE SHEATH OUT, APPROXIMATELY EIGHT CENTIMETERS OF THE SHEATH HAD SEPARATED AND WAS MISSING. A VERY SMALL AMOUNT, APPROXIMATELY TWO CENTIMETERS, OF SHEATH ¿POSSIBLY¿ REMAINED IN THE HUB. IT IS UNKNOWN IF THE ACCESS SITE WAS SCARRED OR CALCIFIED, OR IF RESISTANCE WAS ENCOUNTERED DURING INSERTION OF THE DEVICE; HOWEVER, PER THE REPORTER, BECAUSE THE SURGEON USED A ¿KNIFE¿ TO CUT THE SKIN, SLIGHT RESISTANCE IS ASSUMED. THE DEVICE WAS NOT ADVANCED OR REMOVED THROUGH A PREVIOUSLY PLACED CLOSURE DEVICE. THE ORIGINAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS INITIALLY SENT TO THE RECOVERY ROOM WITH THE SEPARATED SHEATH FRAGMENT IN THE BODY; HOWEVER, THE PATIENT WENT BACK TO THE OPERATING ROOM FOR REMOVAL OF THE FRAGMENT VIA SURGICAL CUT DOWN. THE FRAGMENT, WHICH WAS FOUND IN THE POPLITEAL ARTERY, WAS SUCCESSFULLY REMOVED, AND NOTHING REMAINED IN THE PATIENT.
AS REPORTED, DURING A PROCEDURE INVOLVING ENDOVASCULAR REPAIR OF AN AORTIC ANEURYSM, AN UNSPECIFIED MICROPUNCTURE INTRODUCER SET'S SHEATH SEPARATED. REPORTEDLY, THE SHEATH WAS RETAINED IN THE PATIENT. AFTER RETRIEVAL IT WAS NOTED THAT ONE END OF THE SHEATH APPEARED "SHEARED." AN UNSPECIFIED ADDITIONAL INTERVENTION WAS PERFORMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 699257 | DYB INTRODUCER, CATHETER | DYB | COOK INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| R |