MAUDE Adverse Event Report: COOK VANDERGRIFT INC COOK-SWARTZ DOPPLER PROBE

Catalog Number DP-SDP001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Type  Injury  

Event Description

Literature review identifies flap failures in a retrospective study conducted between 2001 and 2011.The cook doppler was used to monitor all buried flap procedures, where three of the flaps failed.In review of the 134 buried free flaps performed by levine and his team, for single-stage breast reconstruction mastectomy, the incidence of significant complications was low.Four flaps underwent reexploration for venous obstruction.Of those, three flaps(2.2%) ultimately failed and were debrided.Tissue expanders were placed at the time of the flap take-back.Two failed flaps were ultimately replaced with implants and the other flap underwent transverse upper gracilis flap reconstruction.

Manufacturer Narrative

Product code: itx.Pma/510(k): k171272.The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.

Manufacturer Narrative

D2b: product code: itx.G5: pma/510(k): k171272.A device was not returned on this complaint, therefore a physical investigation could not be performed and the customer's complaint could not be confirmed other than testimony/literature.The complaint entered within trackwise: "levine et al 2013: doppler probe created a kink in the vein." the device history record (dhr) could not be reviewed due to the device had an unknown lot.The complaint will be monitored per the cvi complaint handling and post market surveillance processes.A risk assessment will be performed and documented in the complaint summary tab within 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.

• Brand Name: COOK-SWARTZ DOPPLER PROBE
• 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: 13423143
• MDR Text Key: 289456526
• Report Number: 2522007-2022-00001
• 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: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/12/2022
• Initial Date FDA Received: 02/02/2022
• Supplement Dates Manufacturer Received: 01/12/2022
• Supplement Dates FDA Received: 05/06/2022
• 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): Required Intervention