SELECTIVE SALPINGOGRAPHY CATHETER
Report
- Report Number
- 1820334-2021-02514
- Event Type
- Malfunction
- Date Received
- November 19, 2021
- Date of Event
- November 8, 2021
- Report Date
- January 27, 2022
- Manufacturer
- COOK INC
- Product Code
- LKF
- UDI-DI
- 00827002173590
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
NAME AND ADDRESS- PHONE:(B)(6). PMA/510(K) #- K181770. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
EVENT DESCRIPTION: AS REPORTED, THE TIP OF A SELECTIVE SALPINGOGRAPHY CATHETER WAS FOUND TO BE BROKEN WHEN REMOVING THE DEVICE FROM THE PACKAGING. A PHOTO OF THE DEVICE APPEARS TO SHOW THE TIP PARTIALLY SEPARATED. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS OCCURRENCE. 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, THE INSTRUCTIONS FOR USE, AND QUALITY CONTROL DATA. ONE SELECTIVE SALPINGOGRAPHY CATHETER WAS RETURNED FOR INVESTIGATION. INSPECTION OF THE RETURNED DEVICE NOTED: THE DEVICE WAS RETURNED IN OPEN PACKAGING. THE TIP OF THE CATHETER SHOWS DAMAGE AT APPROXIMATELY 7 MM FROM THE DISTAL TIP. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. BECAUSE THERE WERE 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 THE FIELD. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THE REPORTED EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: HOW SUPPLIED "UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." THE MOST PROBABLE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED, AND WE WILL CONTINUE TO MONITOR 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.
AS REPORTED, THE TIP OF A SELECTIVE SALPINGOGRAPHY CATHETER WAS FOUND TO BE BROKEN WHEN REMOVING THE DEVICE FROM THE PACKAGING. A PHOTO OF THE DEVICE APPEARS TO SHOW THE TIP PARTIALLY SEPARATED. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS OCCURRENCE.
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1740965 | SELECTIVE SALPINGOGRAPHY CATHETER | LKF CANNULA, MANIPULATOR/INJECTOR, UTERINE | LKF | COOK INC | G17359 | 13463514 | 00827002173590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Female |