ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE
Report
- Report Number
- 1820334-2022-00127
- Event Type
- Malfunction
- Date Received
- January 27, 2022
- Report Date
- April 27, 2022
- Manufacturer
- COOK INC
- Product Code
- DQX
- UDI-DI
- 00827002096080
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
OCCUPATION = ACCESS COORDINATOR. PMA/510(K) NUMBER = K182985. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
SUMMARY OF EVENT: AS REPORTED, THIRTY ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDES WERE STICKY AND DIFFICULT TO ADVANCE. THIS OCCURRED DURING FISTULAGRAMS, THROMBECTOMIES, AND DURING CATHETER INSERTIONS. THERE HAS BEEN NO REPORT THAT ANY PATIENT REQUIRED ADDITIONAL PROCEDURES OR EXPERIENCED ANY ADVERSE EFFECTS FROM THESE EVENTS. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, 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. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE FOUND. ONE ADDITIONAL COMPLAINT WAS FOUND ON THIS LOT; HOWEVER, THE COMPLAINT WAS REPORTED BY THE SAME USER FACILITY AND REFERENCES A SPECIFIC EVENT. ALTHOUGH THERE HAS BEEN A TOTAL OF TWO LOT RELATED COMPLAINTS FOR THIS FAILURE MODE, THERE IS NO SUSPECTED MANUFACTURING CAUSE OF THIS FAILURE. THERE ARE 100% INSPECTIONS TO CAPTURE THIS FAILURE MODE PRIOR TO DISTRIBUTION AND THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED. THE PRODUCT IFU STATES ¿FLUSH THE WIRE GUIDE HOLDER BY ATTACHING OR PRESSING A SYRINGE WITH SALINE, HEPARINIZED SALINE SOLUTION, OR STERILE WATER TO THE FITTING OR OPENING OF THE WIRE GUIDE HOLDER. INJECT ENOUGH SOLUTION TO WET THE WIRE SURFACE ENTIRELY. THIS WILL ACTIVATE THE AQ COATING.¿ 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. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT A COMPONENT FAILURE UNRELATED TO MANUFACTURING CONTRIBUTED TO THIS INCIDENT. 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.
AS REPORTED, THIRTY ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDES WERE STICKY AND DIFFICULT TO ADVANCE. THIS OCCURRED DURING FISTULAGRAMS, THROMBECTOMIES, AND DURING CATHETER INSERTIONS. THERE HAS BEEN NO REPORT THAT ANY PATIENT REQUIRED ADDITIONAL PROCEDURES OR EXPERIENCED ANY ADVERSE EFFECTS FROM THESE EVENTS.
NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS REPORT WAS SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 326928 | ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE | DQX WIRE, GUIDE, CATHETER | DQX | COOK INC | G09608 | 14233583 | 00827002096080 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |