PERFORMER INTRODUCER
Report
- Report Number
- 1820334-2023-01176
- Event Type
- Malfunction
- Date Received
- August 30, 2023
- Report Date
- December 27, 2023
- Manufacturer
- COOK INC
- Product Code
- DYB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
E1: CUSTOMER NAME AND ADDRESS = (B)(6). G4: PMA/510(K) NUMBER = K171999. 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, UNAVAILABLE, OR UNCHANGED. CORRECTION - E1: (B)(6). SUMMARY OF EVENT: AS REPORTED, DURING AN UNKNOWN PROCEDURE, A PERFORMER INTRODUCER REPORTEDLY HAD "NO VALVE". THE SHEATH WAS EXCHANGED. 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 CUSTOMER DID NOT RETURN THE COMPLAINT DEVICE TO COOK FOR INVESTIGATION. A SEARCH OF SALES FOUND TWO POSSIBLE LOT NUMBERS FOR THE COMPLIANT DEVICE, 15103055 AND 15367917. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO RELEVANT NON-CONFORMANCES ON EITHER LOT. TWO ADDITIONAL RELEVANT COMPLAINTS WERE NOTED ON LOT 15367917, FROM THE SAME CUSTOMER AS THE COMPLAINT DEVICE. THE PRODUCT IFU STATES, ¿ALL INSTRUMENTS OR CATHETERS USED WITH THIS PRODUCT SHOULD MOVE FREELY THROUGH THE VALVE AND SHEATH. DAMAGE TO THE VALVE/INTRODUCER MAY RESULT WHEN THE FIT IS TIGHT.¿ THE INFORMATION PROVIDED UPON REVIEW OF THE DEVICE MASTER RECORD (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 OUT IN THE FIELD. BASED ON A REVIEW OF THE DEVICE MASTER RECORD (DMR), COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. BASED ON THE AVAILABLE INFORMATION AND RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT THE CAUSE OF THIS COMPLAINT COULD NOT BE ESTABLISHED. 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 AN UNKNOWN PROCEDURE, A PERFORMER INTRODUCER REPORTEDLY HAD "NO VALVE". THE SHEATH WAS EXCHANGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1315153 | PERFORMER INTRODUCER | DYB INTRODUCER, CATHETER | DYB | COOK INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |