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 Necrosis (1971)

Event Type  Injury  

Manufacturer Narrative

Common name: transducer, ultrasonic, diagnostic.Product code: itx.Pma/510(k): 171272.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.

Event Description

This complaint identifies a retrospective study regarding the cook-swartz doppler flow probe.The main postoperative complication of free flap is perfusion compromise.Urgent intervention is critical to increase the chances of flap survival.Invasive flap perfusion monitoring with direct blood flow feedback through the doppler flow probe.Between 2012 and 2016, 35 patients under went breast reconstruction or defect coverage after trauma with a deep inferior epigastric perforator, anterolateral thigh, transverse musculocutaneous gracilis, gracilis, or latissimus dorsi flap in our department.All flaps were monitored with a cook¿swartz probe for 10 days postoperatively.This complaint identifies two flap losses and one partial flap necrosis in three patients.

Manufacturer Narrative

D2 - common name: transducer, ultrasonic, diagnostic d2b ¿ product code: itx g5 ¿ pma/510(k): 171272.Investigation - evaluation a device was not returned for a physical investigation, therefore a physical investigation could not be performed and the customer's complaint could not be confirmed other than by the literature publication.The customer complaint/event that was entered and reported in trackwise: "identifying two total flap losses and one partial flap necrosis." per literature complaint: "results: signal loss was detected in 8 of the 35 cases.On return to the operating room, six were found to be true positives (relevant disruption of flap perfusion) and two were false positives (due to doppler probe displacement).There were also two false negatives, resulting in a slowly progressive partial flap loss.Flap perfusion was restored in three of the six cases (50%) identified by the probe.Following surgical intervention, three of the six cases had persistent problems with perfusion, resulting in two total flap losses and one partial flap necrosis leading to an overall 5.7% total flap loss.Conclusion: postoperative flap perfusion surveillance is a complex matter.Surgical experience is often helpful but not always reliable.The costs, false-positive, and false negative rates associated with invasive perfusion monitoring with cook¿swartz probe make it most appropriate for buried flaps.And ".Two total flap losses and one partial flap necrosis occurred (5.7% total flap loss)." the two total flap losses and one partial flap necrosis that were identified out of the six (6) cases that lost signal were listed as true positives.A true positive scenario is the loss of the doppler signal and disruption of flap perfusion.In these six cases it appears that the cook-swartz doppler flow probe functioned as intended and alerted the appropriate individuals that the perfusion of blood had ceased.Due to the cessation of blood perfusion, intervention was conducted by the physician.Unfortunately, in three of the six interventions perfusion could not be restored and resulted in the loss of two flaps and one partial necrosis.The device history record (dhr) was unable to be reviewed due to the lot was unknown.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

This complaint identifies a retrospective study regarding the cook-swartz doppler flow probe.The main postoperative complication of free flap is perfusion compromise.Urgent intervention is critical to increase the chances of flap survival.Invasive flap perfusion monitoring with direct blood flow feedback through the doppler flow probe.Between 2012 and 2016, 35 patients under went breast reconstruction or defect coverage after trauma with a deep inferior epigastric perforator, anterolateral thigh, transverse musculocutaneous gracilis, gracilis, or latissimus dorsi flap in our department.All flaps were monitored with a cook¿swartz probe for 10 days postoperatively.This complaint identifies two flap losses and one partial flap necrosis in three patients.

• 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: 13998731
• MDR Text Key: 290312959
• Report Number: 2522007-2022-00012
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/11/2022

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: 03/09/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 03/09/2022
• Supplement Dates FDA Received: 07/11/2022
• 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