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

Catalog Number DP-SDP001

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 09/28/2018

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Product code: itx.This event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The physician performed a free rectus flap to the frontal sinus and afterward noticed that the wire was no longer attached and unsure if any of the wire was still inside the patient.The physician reopened the incision and found no probe wire was inside the patient.The entire doppler probe wire had been removed.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: h6- ec method code desc - 1: device not returned (4114) h6- ec results code desc - 1: changed to no findings available (3221) h6- ec conclusions code desc - 1: changed to known inherent risk of device (22) h10- added summary of investigation investigation-evaluation: the dp-sdp001 doppler probe was not returned to cvi for investigation.The customer complaint/event entered into trackwise: "as reported to customer relations, "hi (b)(6).I used the cook internal doppler system for a free flap and some the wire broke off inside the patient.Do you know if the wire is mri compatible?" per complaint form: on friday(b)(6) noticed that the wire was no longer attached and unsure if any was still inside the patient." it is not clear with the information provided if the wire fractured or that the cuff prematurely separated.The ifu was reviewed and listed as a potential adverse events is device dislodgement/migration, also separation of the doppler crystal from the cuff.A risk assessment will be performed per qera 200716.1 and documented in the complaint summary tab.Cvi will continue to monitor this complaint mode per the complaint handling and post market surveillance processes.A dhr review was not conducted, as the lot number was not provided or 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

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: COOK-SWARTZ DOPPLER PROBE
• Type of Device: DIAGNOSTIC ULTRASONIC TRANSDUCER
• Manufacturer (Section D): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 7994502
• MDR Text Key: 124667627
• Report Number: 2522007-2018-00021
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• 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
• Date Manufacturer Received: 09/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention