SAFE-T-J FIXED CORE WIRE GUIDE
Report
- Report Number
- 1820334-2022-00976
- Event Type
- Malfunction
- Date Received
- May 25, 2022
- Date of Event
- May 2, 2022
- Report Date
- September 16, 2022
- Manufacturer
- COOK INC
- Product Code
- DQX
- UDI-DI
- 00827002005297
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(6). PMA/510(K) #: K171764. 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.
INVESTIGATION ¿ EVALUATION: ON 11MAY2022, COOK MEDICAL INC. RECEIVED A COMPLAINT FROM (B)(6) A REPRESENTATIVE AT THE (B)(6) HOSPITAL, LOCATED IN THE CITY OF (B)(6) REPORTING THE FOLLOWING: ON (B)(6) 2022, DURING AN INITIAL INSERTION OF THE MULTIPURPOSE DRAINAGE CATHETER, THE SAFE-T-J FIXED CORE WIRE GUIDE (RPN: TSCF-35-80-3, LOT 14469339), BECAME STUCK. THE WIRE COULD NOT EASILY BE REMOVED FROM THE METAL STYLET AND CATHETER WHILE IN PLACE. THE WIRE APPEARED TO HAVE SNAPPED AND UNCOILED. UPON THE REMOVAL OF THE STYLET / CATHETER COMBO, IT WAS DISCOVERED THE WIRE WAS BROKEN, RESULTING IN COIL ELONGATION, WITHOUT SEPARATION. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL PROCEDURES, AND SPECIFICATIONS OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. COOK COMPLETED A REVIEW OF THE PRODUCT DEVICE MASTER RECORD (DMR) AND CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. IN RESPONSE TO THIS INCIDENT, COOK REVIEWED THE DEVICE HISTORY RECORD (DHR). THE DHR FOR LOT (14469339) CONFIRMED NO RELEVANT RECORDED NONCONFORMANCES. TO DATE, A FURTHER SEARCH OF OUR DATABASE RECORDS REVEALED NO ADDITIONAL COMPLAINTS ASSOCIATED WITH THE REPORTED LOT. SINCE THERE IS OBJECTIVE EVIDENCE THE DHR WAS FULLY EXECUTED, AND THERE ARE NO OTHER LOT-RELATED COMPLAINTS FROM THE FIELD, COOK HAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NON-CONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD, AND THAT THE DEVICE WAS MANUFACTURED TO CURRENT SPECIFICATIONS. BASED ON THE INFORMATION PROVIDED, NO RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, IT WAS DETERMINED THE CAUSE OF THIS EVENT IS TRACED TO A COMPONENT FAILURE WITHOUT A MANUFACTURING OR DESIGN DEFICIENCY. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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. 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.
IT WAS REPORTED A SAFE-T-J FIXED CORE WIRE GUIDE WAS DAMAGED DURING A DRAIN INSERTION PROCEDURE. WHEN REMOVING THE METAL STYLET OF THE CATHETER, THE WIRE WAS REPORTEDLY "SEVERELY KINKED, STRETCHED, AND UNABLE TO BE REMOVED FROM THE INSIDE OF THE STYLET." THIS MADE THE DEVICE UNUSABLE. THERE WAS NO PATIENT HARM AS A RESULT OF THIS OCCURRENCE.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
IN ADDITIONAL INFORMATION RECEIVED ON 31MAY2022, IT WAS REPORTED THAT THE ISSUE OCCURRED DURING THE INITIAL INSERTION OF THE DRAIN. NO SEPARATION OF THE WIRE GUIDE WAS NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 259895 | SAFE-T-J FIXED CORE WIRE GUIDE | DQX WIRE, GUIDE, CATHETER | DQX | COOK INC | N/A | 14469339 | 00827002005297 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |