COOK-SWARTZ DOPPLER PROBE
Report
- Report Number
- 2522007-2024-00018
- Event Type
- Injury
- Date Received
- April 16, 2024
- Report Date
- August 21, 2024
- Manufacturer
- COOK VANDERGRIFT INC
- Product Code
- ITX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE UDI INFORMATION PER 21CFR 803.52(C)(4) AND 21 CFR 803.50(B) THAT IS REQUIRED IS REASONABLY UNKNOWN DUE TO THE DEVICE ITSELF WAS DISCARDED/NOT RETURNED FOR INVESTIGATION AFTER MANUFACTURER REQUESTED FOR THE RETURN AND THE LOT AND MODEL OF THE DEVICE WAS UNKNOWN. E3 - OCCUPATION: UNKNOWN TITLE. G5 ¿ PMA/510(K): K171272. THE DEVICE WAS NOT RETURNED FOR THE COMPLAINT; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED, AND THE CUSTOMER'S COMPLAINT IS ACKNOWLEDGED, BUT COULD NOT BE CONFIRMED, OTHER THAN BY THE CUSTOMER'S TESTIMONY. THE COMPLAINT/EVENT THAT WAS ENTERED AND REPORTED WITHIN TRACKWISE: "WIRE BREAKS WHEN REMOVING LEAD." PER COMPLAINT INFORMATION/ATTACHMENTS/COMMUNICATION, IT WAS STATED THAT THE DEVICE (PROBE) WAS USED ON A PATIENT ALONG WITH THE DEVICE IS IN THE PATIENT. IT WAS ALSO STATED THAT THE INSTRUCTIONS FOR USE WERE ADDRESSED AND TO LET THE SURGEON KNOW THE METAL WIRE PART OF THE PROBE HAS NOT BEEN TESTED FOR MRI COMPATIBILITY, WHILE ANY OF THE WIRE IS PRESENT WITHIN THE PATIENT. THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE VIEWED DUE TO THE LOT NUMBER SPECIFIC TO THIS COMPLAINT WAS UNKNOWN. THIS COMPLAINT MODE IS BEING MONITORED, TRACKED AND TRENDED PER THE CVI POST MARKET SURVEILLANCE AND COMPLAINT HANDLING PROCESSES. A RISK ASSESSMENT WILL BE PERFORMED AND DOCUMENTED IN THE COMPLAINT SUMMARY TAB IN TRACKWISE. 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.
THE EVENT IS CURRENTLY UNDER INVESTIGATION. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE OR UPON COMPLETION OF INVESTIGATION. D2B: PRODUCT CODE: ITX. G5: PMA/510(K): 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 INITIALLY REPORTED TO CUSTOMER RELATIONS: A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT AN UNDERWENT AN UNDISCLOSED PROCEDURE IN WHICH THE COOK-SWARTZ DOPPLER PROBE WAS USED. I AM A PLASTIC SURGEON WITH FOCUS IN MICROSURGICAL BREAST RECONSTRUCTION AND WE AT (B)(6) USE YOUR COOK IMPLANTABLE DOPPLER ALL THE TIME AND LOVE IT. I [PHYSICIAN] AM WONDERING IF I CAN GET MORE INFORMATION ABOUT WHAT THE PRODUCT IS MADE OF ¿ ALL OF THE COMPONENTS. WE [THE FACILITY] HAVE HAD 2 INSTANCES IN WHICH WIRE HAS BROKEN WHEN TRYING TO REMOVE LEADING TO RETAINED DEVICE. I [PHYSICIAN] HAVE SEEN LITERATURE THAT SAYS IT'S LARGELY SAFE, HOWEVER MY [PHYSICIAN] PATIENT HAS BEEN INQUIRING ABOUT EXACTLY WHAT MATERIAL IS LEFT INSIDE OF HER, WHAT KIND OF METAL IT IS MADE OUT OF. CAN YOU PLEASE PROVIDE ME [PHYSICIAN] WITH A LIST OF ALL THE MATERIALS THE DEVICE IS MADE OUT OF SO I [PHYSICIAN] CAN DISCLOSE TO MY PATIENTS IF ASKED IN THIS SCENARIO?
AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT AN UNDERWENT AN UNDISCLOSED PROCEDURE IN WHICH THE COOK-SWARTZ DOPPLER PROBE WAS USED. I AM A PLASTIC SURGEON WITH FOCUS IN MICROSURGICAL BREAST RECONSTRUCTION AND WE AT (B)(6) USE YOUR COOK IMPLANTABLE DOPPLER ALL THE TIME AND LOVE IT. I [PHYSICIAN] AM WONDERING IF I CAN GET MORE INFORMATION ABOUT WHAT THE PRODUCT IS MADE OF ¿ ALL OF THE COMPONENTS. WE [THE FACILITY] HAVE HAD 2 INSTANCES IN WHICH WIRE HAS BROKEN WHEN TRYING TO REMOVE LEADING TO RETAINED DEVICE. I [PHYSICIAN] HAVE SEEN LITERATURE THAT SAYS IT'S LARGELY SAFE, HOWEVER MY [PHYSICIAN] PATIENT HAS BEEN INQUIRING ABOUT EXACTLY WHAT MATERIAL IS LEFT INSIDE OF HER, WHAT KIND OF METAL IT IS MADE OUT OF. CAN YOU PLEASE PROVIDE ME [PHYSICIAN] WITH A LIST OF ALL THE MATERIALS THE DEVICE IS MADE OUT OF SO I [PHYSICIAN] CAN DISCLOSE TO MY PATIENTS IF ASKED IN THIS SCENARIO?
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 672340 | COOK-SWARTZ DOPPLER PROBE | ITX TRANSDUCER, ULTRASONIC, DIAGNOSTIC | ITX | COOK VANDERGRIFT INC | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |