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

Catalog Number DP-SDP001

Device Problems Detachment of Device or Device Component (2907); Audible Prompt/Feedback Problem (4020)

Patient Problem No Code Available (3191)

Event Date 06/24/2018

Event Type  malfunction  

Manufacturer Narrative

This event is currently under investigation.The actual device is not currently available, however a follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

As per report on (b)(6) 2018, a doppler probe failed and the patient had to be taken back to the operating room for an additional surgery.

Event Description

As per report on (b)(6) 2018 a doppler probe failed and the patient had to be taken back to the operating room for an additional surgery.

Manufacturer Narrative

Updates: changed to yes.Changed to pma / 510(k): k171272.H3: changed to yes.H6: changed device code desc 1 udible prompt / feedback (4020).Changed ec method code desc 1 testing of actual/suspected device (10).Added ec method code desc 2 analysis of production records (3331).Changed ec results code desc 1 appropriate term/code not available (4247).Changed ec conclusions code desc 1 cause not established (4315).Explanation: ec results code desc 1 appropriate term/code not available (4247): although the device was returned for analysis, only a partial investigation could take place.A visual inspection was able to be conducted however an functional / electrical evaluation of the device could not take place because the device was cut into 3 pieces by the user rendering a electrical evaluation of the device impossible.Investigation summary: the device was inspected using increased magnification.The cuff was returned fully attached to the crystal per design.A functional test could not be performed on the probe as the cable was cut in two places.One cut was approximately 29cm from the crystal (distal tip), and the other cut was approximately 97.5 cm from the proximal connector.Excess solder or any defect of the solder was not observed on the edge of the crystal where the two wires are soldered to the crystal face.The proximal end connector components had no signs of a defect or damage.The customers complaint could not be reproduced as the device was returned in 3 pieces from being cut with a sharp tool.There is no evidence of a manufacturing defect.A device history review was conducted, and there is no evidence that defective product was shipped.There are no signs that this device was not manufactured to current specifications.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
• Type of Device: DIAGNOSTIC ULTRASONIC TRANSDUCER
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 7847762
• MDR Text Key: 119797063
• Report Number: 2522007-2018-00018
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00827002213630
• UDI-Public: (01)00827002213630(17)200531(10)N147007
• Combination Product (y/n): N
• PMA/PMN Number: K022649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: DP-SDP001
• Device Lot Number: N147007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Date Manufacturer Received: 08/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention