COOK-SWARTZ DOPPLER PROBE
Report
- Report Number
- 2522007-2022-00024
- Event Type
- Injury
- Date Received
- November 23, 2022
- Report Date
- March 23, 2023
- Manufacturer
- COOK VANDERGRIFT INC
- Product Code
- ITX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PRODUCT CODE: ITX . PMA/510(K): K17122. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION. 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.
D2B: PRODUCT CODE: ITX . G5: PMA/510(K): K171272. A DEVICE WAS NOT RETURNED FOR THIS COMPLAINT THEREFORE A PHYSICAL INVESTIGATION COULD NOT BE PERFORMING MAKING IT UNABLE TO CONFIRM THE COMPLAINT OTHER THAN BY CUSTOMER'S TESTIMONY/JOURNAL ARTICLE. THE CUSTOMER COMPLAINT/EVENT THAT WAS ENTERED WITHIN TRACKWISE: "RETAINED PROBE WAS IDENTIFIED IN PATIENT." PER THE JOURNAL ARTICLE: "DURING THE STUDY PERIOD, IMPLANTABLE DOPPLER PROBES WERE PLACED IN 323 FREE TISSUE TRANSFER PATIENTS. EIGHTEEN (5.6%) PATIENTS WERE IDENTIFIED WITH AN INCIDENTAL RADIOGRAPHIC FINDING OF A RETAINED PROBE AND WERE SUBSEQUENTLY INCLUDED IN THE ANALYSIS. REVIEWING THE MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE AVAILABLE ON FOOD AND DRUG ADMINISTRATION (FDA) WEBSITE, THE AUTHORS IDENTIFIED A TOTAL OF 28 REPORTS RELATED WITH COOK-SWARTZ COMPLICATIONS.¿ THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED DUE TO THE LOT WAS UNKNOWN SPECIFIC TO THIS COMPLAINT. 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 ARTICLE STATED THE FOLLOWING: IN THIS SERIES, REMOVAL OF THE DEVICE WAS ATTEMPTED AT A MEAN OF 36 (RANGE, 5-165) DAYS FOLLOWING SURGERY. POTENTIAL DEVICE¿RELATED COMPLICATIONS OCCURRED IN ONLY 1 (5.5%) PATIENT, WHO UNDERWENT LOWER EXTREMITY RECONSTRUCTION AFTER ONCOLOGIC RESECTION AND SUBSEQUENTLY DEVELOPED CHRONIC DRAINING SINUS 14 MONTHS AFTER SURGERY. THE ETIOLOGY OF THE DRAINING SINUS WAS ATTRIBUTED TO THE RETAINED FILAMENT AND WAS SUCCESSFULLY TREATED WITH REMOVAL OF THE RETAINED FILAMENT.
THE ARTICLE STATED THE FOLLOWING: IN THIS SERIES, REMOVAL OF THE DEVICE WAS ATTEMPTED AT A MEAN OF 36 (RANGE, 5-165) DAYS FOLLOWING SURGERY. POTENTIAL DEVICE¿RELATED COMPLICATIONS OCCURRED IN ONLY 1 (5.5%) PATIENT, WHO UNDERWENT LOWER EXTREMITY RECONSTRUCTION AFTER ONCOLOGIC RESECTION AND SUBSEQUENTLY DEVELOPED CHRONIC DRAINING SINUS 14 MONTHS AFTER SURGERY. THE ETIOLOGY OF THE DRAINING SINUS WAS ATTRIBUTED TO THE RETAINED FILAMENT AND WAS SUCCESSFULLY TREATED WITH REMOVAL OF THE RETAINED FILAMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2707918 | COOK-SWARTZ DOPPLER PROBE | Transducer, ultrasonic, diagnostic | ITX | COOK VANDERGRIFT INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |