ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE
Report
- Report Number
- 1820334-2022-01068
- Event Type
- Malfunction
- Date Received
- June 15, 2022
- Date of Event
- May 10, 2022
- Report Date
- August 24, 2022
- Manufacturer
- COOK INC
- Product Code
- DQX
- UDI-DI
- 00827002091054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PMA/510K #: K182985. 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.
SUMMARY OF EVENT: AS REPORTED, DURING INSPECTION IT WAS DISCOVERED THAT A PIECE OF HAIR WAS INSIDE THE PACKAGING OF A ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE. THE DEVICE WAS NOT INVOLVED IN A PROCEDURE. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION OF A PHOTO PROVIDED BY THE CUSTOMER WAS PERFORMED. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. A PHOTO WAS PROVIDED BY THE CUSTOMER, HOWEVER, SHOWING HAIR-LIKE FOREIGN MATTER IN THE SEALED DEVICE PACKAGE. THE PRODUCT IFU STATES, ¿DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE.¿ A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. TWO RELATED NON-CONFORMANCES WERE FOUND; HOWEVER, ALL NON-CONFORMING PRODUCT WAS RE-WORKED, AND 100% INSPECTIONS ARE IN PLACE. THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, IFU SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION; HOWEVER, THERE IS NO EVIDENCE OF ADDITIONAL 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 MANUFACTURING/QUALITY CONTROL DEFICIENCY CONTRIBUTED TO THIS EVENT. 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, DURING INSPECTION IT WAS DISCOVERED THAT A PIECE OF HAIR WAS INSIDE THE PACKAGING OF A ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE. THE DEVICE WAS NOT INVOLVED IN A PROCEDURE.
NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1658507 | ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE | DQX WIRE, GUIDE, CATHETER | DQX | COOK INC | G09105 | 14494899 | 00827002091054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |