MAUDE Adverse Event Report: COOK VANDERGRIFT INC COOK-SWARTZ DOPPLER PROBE; Transducer, ultrasonic, diagnostic

Catalog Number DP-SDP001

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Fluid Discharge (2686); Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

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.

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: COOK-SWARTZ DOPPLER PROBE
• Type of Device: Transducer, ultrasonic, diagnostic
• Manufacturer (Section D): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer (Section G): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer Contact: brian johnston ; 1186 montgomery lane; vandergrift, PA 15690 ; 7248458621
• MDR Report Key: 15855196
• MDR Text Key: 304278580
• Report Number: 2522007-2022-00024
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DP-SDP001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other