MAUDE Adverse Event Report: COOK-SWARTZ DOPPLER PROBE; DIAGNOSTIC ULTRASONIC TRANSDUCER

Catalog Number DP-SDP001

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Perforation of Vessels (2135)

Event Date 04/27/2021

Event Type  Injury  

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.

Event Description

Following the completion of the removal of the aggressive maxilla orbital h&n tumor, two flaps were harvested for the reconstruction.A fibula free flap was used for the reconstruction of the maxilla and an alt flap to close the soft tissue.Both free flaps had a dp-sdp001 placed around the artery.10 days post operation and after no issues in blood flow was detected, the probes came to be removed.Removal was performed on the h&n ward by a ward nurse who wasn't completely familiar with the cook doppler probe.The fibula flap monitor probe was removed easily with no incident.Upon removal of the alt flap it was reported that excessive force was required to remove wire and caused pain to patient.24 hours later the alt flap was found to have an issue with blood flow and the patient returned to operating room for revision surgery.Upon opening, the arterial vessel leading to blood flow loss was separated and the flap had failed due to duration of ischemia.Afterwards, an alternative pectoralis major flap was harvested to anastomose to the vein of the recipient site.This led to a further 9 hour surgery and prolonged in-patient stay in hospital.

Manufacturer Narrative

Investigation - evaluation: no device was returned on this complaint.The complaint/event entered into trackwise: "patient to return to theatre for surgery." per complaint / customer testimony: "this was performed on the h&n ward by a ward nurse who wasn't completely familiar with the cook implantable doppler.The fibula flap monitor probe was removed easily with no incident.Upon removal of the alt flap, there was reported excessive force required and pain from the patient.24 hours later the alt flap was found to have an issue with blood flow and the patient returned to surgery for revision surgery." the device history records (dhr) showed no signs of a nonconforming product.Both lots that were listed in complaint were reviewed.The complaint will be monitored for trends per the complaint handling and the post market surveillance processes.A risk assessment will be performed and documented in the complaint summary tab of trackwise.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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

No new patient or event information to report.

• Brand Name: COOK-SWARTZ DOPPLER PROBE
• Type of Device: DIAGNOSTIC ULTRASONIC TRANSDUCER
• MDR Report Key: 11875903
• MDR Text Key: 266244315
• Report Number: 2522007-2021-00017
• 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: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• 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
• 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