DYB INTRODUCER, CATHETER
Report
- Report Number
- 1820334-2025-01005
- Event Type
- Injury
- Date Received
- August 18, 2025
- Date of Event
- July 6, 2025
- Report Date
- January 16, 2026
- Manufacturer
- COOK INC
- Product Code
- DYB
- PMA / PMN Number
- K240589
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
SUMMARY OF EVENT: AS REPORTED, DURING PLACEMENT OF AN ARTERIAL LINE, AN UNSPECIFIED COOK MICROPUNCTURE SET¿S WIRE SEPARATED. PER THE REPORTER, THE PATIENT WAS ALREADY IN SHOCK AND RECEIVING MULTIPLE VASOPRESSORS AT THE TIME OF ARTERIAL LINE PLACEMENT. A SMALL AMOUNT OF RESISTANCE WAS ENCOUNTERED UPON INSERTION OF THE COOK WIRE GUIDE; HOWEVER, THE RESISTANCE RESOLVED. REPORTEDLY, THE PHYSICIAN WAS UNABLE TO RETRACT THE WIRE AND APPLIED SUBSTANTIAL FORCE IN AN EFFORT TO REMOVE IT THROUGH THE ENTRY NEEDLE; HOWEVER, APPROXIMATELY 1.5-CENTIMETERS OF THE DISTAL END OF THE WIRE FRACTURED/SHEARED OFF. THE SEPARATED WIRE FRAGMENT WAS VISUALIZED WITH ULTRASOUND. THE FRAGMENT REPORTEDLY APPEARED TO BE OUTSIDE OF THE VESSEL, AND THERE WAS NO CLINICAL EVIDENCE OF ACUTE LIMB ISCHEMIA. BLOOD LOSS DID NOT OCCUR. ADDITIONAL INFORMATION WAS RECEIVED 25AUG2025. ULTRASOUND-GUIDED ACCESS WAS OBTAINED IN THE RIGHT RADIAL ARTERY, AND THE ACCESS SITE REPORTEDLY LOOKED NORMAL. BLOOD RETURN WAS NOTED UPON INSERTION OF THE ACCESS NEEDLE, PRIOR TO ADVANCEMENT OF THE WIRE GUIDE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A ¿STANDARD ARTERIAL LINE NEEDLE/CATHETER¿ MORE PROXIMALLY IN THE RADIAL ARTERY. THE SEPARATED WIRE FRAGMENT REMAINED IN THE PATIENT AND WAS REPORTEDLY ¿LOOPED AROUND¿ AND POSSIBLY WITHIN THE DISTAL RIGHT RADIAL ARTERY. PER THE PHYSICIAN, THE FRAGMENT WOULD HAVE ULTIMATELY NEEDED TO BE REMOVED SURGICALLY; HOWEVER, THE PATIENT EXPIRED DUE TO OTHER CAUSES. REPORTEDLY, THE PATIENT WAS NEUROLOGICALLY DEVASTATED PRIOR TO PLACEMENT OF THE ARTERIAL LINE, AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT RESULTING FROM THE SEPARATED AND RETAINED WIRE FRAGMENT. INVESTIGATION EVALUATION: REVIEWS OF THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, 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; THEREFORE, THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE REVIEWED. THE PRODUCT IFU WARNS "DO NOT WITHDRAW THE WIRE GUIDE THROUGH THE INTRODUCER NEEDLE, BREAKAGE MAY RESULT. IF THE WIRE GUIDE TIP MUST BE WITHDRAWN WHILE THE NEEDLE IS INSERTED, REMOVE BOTH THE NEEDLE AND THE WIRE AS A UNIT.¿ 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 SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT FAILURE TO FOLLOW INSTRUCTIONS CONTRIBUTED TO THIS EVENT. THE PHYSICIAN REPORTEDLY APPLIED SUBSTANTIAL FORCE IN AN EFFORT TO REMOVE THE WIRE THROUGH THE ENTRY NEEDLE. THE PRODUCT IFU WARNS "DO NOT WITHDRAW THE WIRE GUIDE THROUGH THE INTRODUCER NEEDLE, BREAKAGE MAY RESULT. IF THE WIRE GUIDE TIP MUST BE WITHDRAWN WHILE THE NEEDLE IS INSERTED, REMOVE BOTH THE NEEDLE AND THE WIRE AS A UNIT.¿ 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.
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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. ADDITIONAL INFORMATION: B5. 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.
AS REPORTED, DURING PLACEMENT OF AN ARTERIAL LINE, AN UNSPECIFIED COOK MICROPUNCTURE SET¿S WIRE SEPARATED. PER THE REPORTER, THE PATIENT WAS ALREADY IN SHOCK AND RECEIVING MULTIPLE VASOPRESSORS AT THE TIME OF ARTERIAL LINE PLACEMENT. A SMALL AMOUNT OF RESISTANCE WAS ENCOUNTERED UPON INSERTION OF THE COOK WIRE GUIDE; HOWEVER, THE RESISTANCE RESOLVED. REPORTEDLY, THE PHYSICIAN WAS UNABLE TO RETRACT THE WIRE AND APPLIED SUBSTANTIAL FORCE IN AN EFFORT TO REMOVE IT THROUGH THE ENTRY NEEDLE; HOWEVER, APPROXIMATELY 1.5-CENTIMETERS OF THE DISTAL END OF THE WIRE FRACTURED/SHEARED OFF. THE SEPARATED WIRE FRAGMENT WAS VISUALIZED WITH ULTRASOUND. THE FRAGMENT REPORTEDLY APPEARED TO BE OUTSIDE OF THE VESSEL, AND THERE WAS NO CLINICAL EVIDENCE OF ACUTE LIMB ISCHEMIA. BLOOD LOSS DID NOT OCCUR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
ADDITIONAL INFORMATION WAS RECEIVED 25AUG2025. ULTRASOUND-GUIDED ACCESS WAS OBTAINED IN THE RIGHT RADIAL ARTERY, AND THE ACCESS SITE REPORTEDLY LOOKED NORMAL. BLOOD RETURN WAS NOTED UPON INSERTION OF THE ACCESS NEEDLE, PRIOR TO ADVANCEMENT OF THE WIRE GUIDE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A ¿STANDARD ARTERIAL LINE NEEDLE/CATHETER¿ MORE PROXIMALLY IN THE RADIAL ARTERY. THE SEPARATED WIRE FRAGMENT REMAINED IN THE PATIENT AND WAS REPORTEDLY ¿LOOPED AROUND¿ AND POSSIBLY WITHIN THE DISTAL RIGHT RADIAL ARTERY. PER THE PHYSICIAN, THE FRAGMENT WOULD HAVE ULTIMATELY NEEDED TO BE REMOVED SURGICALLY; HOWEVER, THE PATIENT EXPIRED DUE TO OTHER CAUSES. REPORTEDLY, THE PATIENT WAS NEUROLOGICALLY DEVASTATED PRIOR TO PLACEMENT OF THE ARTERIAL LINE, AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT RESULTING FROM THE SEPARATED AND RETAINED WIRE FRAGMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2044456 | DYB INTRODUCER, CATHETER | DYB | COOK INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Male | ARGON GUIDEWIRE #85210. |