PERFORMER INTRODUCER
Report
- Report Number
- 1820334-2022-00186
- Event Type
- Malfunction
- Date Received
- February 9, 2022
- Report Date
- May 24, 2022
- Manufacturer
- COOK INC
- Product Code
- DYB
- UDI-DI
- 00827002270237
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PMA/510(K) #: K171999. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
PMA/510(K) #: K171999. 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, A PERFORMER INTRODUCER'S TIP BROKE DURING AN UNKNOWN PROCEDURE. 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 COMPLAINANT DID NOT RETURN THE COMPLAINT DEVICE TO COOK FOR INVESTIGATION. COOK COMPLETED A REVIEW OF THE DEVICE HISTORY RECORD (DHR). THE DHR FOR THE REPORTED LOT RECORDED NO RELEVANT NON-CONFORMANCES. A RELATED LOT RECORDED ONE POSSIBLE RELEVANT NON-CONFORMANCE FOR "DISTAL END, DIFFICULT TO WIRE, WILL NOT WIRE", HOWEVER, THIS DEVICE WAS SCRAPPED. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER RELATED COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. COOK HAS CONCLUDED THAT NO NONCONFORMING PRODUCT FROM THIS LOT EXISTS IN HOUSE OR IN THE FIELD. A DOCUMENT REVIEW WAS COMPLETED. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: HOW SUPPLIED ¿UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ COOK HAS CONCLUDED THAT COMPONENT FAILURE UNRELATED TO MANUFACTURING CONTRIBUTED TO THIS INCIDENT. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. PER THE QUALITY ENGINEERING 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.
AS REPORTED, A PERFORMER INTRODUCER'S TIP BROKE DURING AN UNKNOWN PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
AS REPORTED, A PERFORMER INTRODUCER'S TIP BROKE DURING AN UNKNOWN PROCEDURE. 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 |
|---|---|---|---|---|---|---|---|
| 683887 | PERFORMER INTRODUCER | DYB INTRODUCER, CATHETER | DYB | COOK INC | G27023 | 14336087 | 00827002270237 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |