DQX WIRE, GUIDE, CATHETER
Report
- Report Number
- 1820334-2020-01518
- Event Type
- Malfunction
- Date Received
- August 19, 2020
- Date of Event
- August 18, 2020
- Report Date
- June 3, 2021
- Manufacturer
- COOK INC
- Product Code
- DQX
- UDI-DI
- 00827002068421
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
DESCRIPTION OF EVENT: AS REPORTED, DURING A PERCUTANEOUS TRANSHEPATIC GALLBLADDER DRAINAGE (PTGBD) PROCEDURE VIA ABDOMINAL ACCESS, A BENTSON STRAIGHT HEPARIN COATED FIXED CORE WIRE GUIDE WAS FOUND TO BE KINKED AND SHARP, WITH THE MANDRIL PROTRUDING FROM THE DEVICE. THIS OCCURRED DURING PREPARATION OF THE DEVICE, WHICH DID NOT MAKE PATIENT CONTACT. IT IS UNKNOWN IF THE USER ATTEMPTED TO ALTER THE SHAPE OF THE WIRE DURING PREPARATION. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. INVESTIGATION ¿ EVALUATION: A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, AND SPECIFICATIONS. THE COMPLAINANT RETURNED ONE BENTSON STRAIGHT HEPARIN COATED FIXED CORE WIRE GUIDE TO COOK FOR INVESTIGATION. PHYSICAL EXAMINATION OF THE RETURNED DEVICE SHOWED THERE WAS NO SAFETY WIRE WELD BREAKAGE. THE MANDRIL WAS PROTRUDING 5CM FROM THE DISTAL TIP. THE LENGTH OF PROTRUSION WAS 5MM. NO OTHER ISSUES WERE NOTED DURING THE ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. BECAUSE THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. THE COMPLAINT PRODUCT DOES NOT COME SUPPLIED WITH AN INSTRUCTIONS FOR USE (IFU) INSERT, SO A REVIEW OF THE PRODUCT LABELING COULD NOT BE COMPLETED. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. IT IS POSSIBLE THE USER TRIED TO MANIPULATE THE CURVE WHICH CAN SEPARATE THE COILS AND THEREFORE ALLOW MANDRIL PROTRUSION. HOWEVER, THIS IS ONLY POSSIBLE. THEREFORE, THE INVESTIGATION CONCLUSION FOR THIS COMPLAINT IS CAUSE TRACED TO A COMPONENT FAILURE WITHOUT A MANUFACTURING OR DESIGN DEFICIENCY. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. CORRECTION: C. 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.
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.
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
RPN= (B)(4). ALTHOUGH THE COMPLAINT DEVICE IS NOT MARKETED IN THE UNITED STATES, SIMILAR DEVICES ARE MANUFACTURED AND MARKETED IN THE U.S. BY COOK, INC. THE SIMILAR DEVICES ARE PRE-AMENDMENT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
AS REPORTED, DURING A PERCUTANEOUS TRANSHEPATIC GALLBLADDER DRAINAGE (PTGBD) PROCEDURE VIA ABDOMINAL ACCESS, A BENTSON STRAIGHT HEPARIN COATED FIXED CORE WIRE GUIDE WAS FOUND TO BE KINKED AND SHARP, WITH THE MANDRIL PROTRUDING FROM THE DEVICE. THIS OCCURRED DURING PREPARATION OF THE DEVICE, WHICH DID NOT MAKE PATIENT CONTACT. IT IS UNKNOWN IF THE USER ATTEMPTED TO ALTER THE SHAPE OF THE WIRE DURING PREPARATION. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE HAS BEEN NO REPORT THAT ANY PART OF THE DEVICE REMAINED IN THE PATIENT'S BODY, THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES, OR THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 888998 | DQX WIRE, GUIDE, CATHETER | DQX | COOK INC | 9833342 | 00827002068421 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |