ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE
Report
- Report Number
- 1820334-2024-00764
- Event Type
- Malfunction
- Date Received
- June 4, 2024
- Date of Event
- April 18, 2024
- Report Date
- October 22, 2024
- Manufacturer
- COOK INC
- Product Code
- DQX
- UDI-DI
- 00827002096080
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
G4: PMA/510(K) NUMBER = K182985; E1: CUSTOMER PHONE = +(B)(6). 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. SUMMARY OF EVENT: AS REPORTED, DURING AN UNKNOWN PROCEDURE, FOUR ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDES ¿BROKE AT THE DISTAL END DURING USE.¿ REPORTEDLY, THE WIRES BECAME PROGRESSIVELY ¿MORE DAMAGED¿ AT THE DISTAL END. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME WAS REQUESTED BUT NOT PROVIDED. CORRECTED INFORMATION: D4, H6 (ANNEX A). INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO RELEVANT NON-CONFORMANCES ON THE LOT. A REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELEVANT COMPLAINTS FOR THIS LOT NUMBER. THE PRODUCT IFU STATES ¿THIS PRODUCT IS A DELICATE INSTRUMENT. AVOID FORCEFUL ANGULATION.¿ 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, DHR, 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 A COMPONENT FAILURE, UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES, CONTRIBUTED TO THIS EVENT. THE CUSTOMER DID NOT RESPOND TO REQUESTS FOR ADDITIONAL INFORMATION AND THE EXACT CONDITIONS EXPERIENCED DURING THE EVENT CANNOT BE DUPLICATED. 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.
EVENT DESCRIPTION: AS REPORTED, DURING AN UNKNOWN PROCEDURE, FOUR ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDES "BROKE AT THE DISTAL END DURING USE." REPORTEDLY, THE WIRES BECAME PROGRESSIVELY "MORE DAMAGED" AT THE DISTAL END. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION RECEIVED ON 23SEP2024. THE WIRES WERE NOT ALTERED PRIOR TO USE AND LATEX GLOVES WERE WORN. RESISTANCE WAS NOT FELT UPON INSERTION, AND THE WIRES WERE NOT PULLED/MANIPULATED BACKWARD THROUGH A NEEDLE OR OTHER METAL INSTRUMENT. PHYSIOLOGICAL SERUM WAS USED TO ACTIVATE THE COATING IMMEDIATELY BEFORE USE/REUSE. EACH WIRE WAS USED ONE TIME, AND THE WIRES WERE KEPT HYDRATED WHILE NOT IN USE. FLAKING/CHIPPING WAS NOTED ON THE WIRES, AND SOME OF THE WIRES FELT "GRAINY"; HOWEVER, THE COLOR REMAINED WHITE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE OCCURRENCE. THE ADDITIONAL INFORMATION PROVIDED ON 23SEP2024 DID NOT ALTER THE INVESTIGATION FINDINGS, AND THE CONCLUSION IS UNCHANGED FROM THE PREVIOUSLY REPORTED MDR SUBMISSION ON 12AUG2024. 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.
AS REPORTED, DURING AN UNKNOWN PROCEDURE, FOUR ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDES ¿BROKE AT THE DISTAL END DURING USE.¿ REPORTEDLY, THE WIRES BECAME PROGRESSIVELY ¿MORE DAMAGED¿ AT THE DISTAL END. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
ADDITIONAL INFORMATION RECEIVED ON 23SEP2024. THE WIRES WERE NOT ALTERED PRIOR TO USE AND LATEX GLOVES WERE WORN. RESISTANCE WAS NOT FELT UPON INSERTION, AND THE WIRES WERE NOT PULLED/MANIPULATED BACKWARD THROUGH A NEEDLE OR OTHER METAL INSTRUMENT. PHYSIOLOGICAL SERUM WAS USED TO ACTIVATE THE COATING IMMEDIATELY BEFORE USE/REUSE. EACH WIRE WAS USED ONE TIME, AND THE WIRES WERE KEPT HYDRATED WHILE NOT IN USE. FLAKING/CHIPPING WAS NOTED ON THE WIRES, AND SOME OF THE WIRES FELT "GRAINY"; HOWEVER, THE COLOR REMAINED WHITE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 660056 | ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE | DQX WIRE, GUIDE, CATHETER | DQX | COOK INC | G09608 | 15644440 | 00827002096080 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |