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

Model Number N/A

Device Problems Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 09/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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

The customer reported that the cook-swartz doppler probe did not adhere to the silastic cuff that wraps around the vessel.This allegedly resulted in post operative complications, and may have reportedly necessitated the need for a trip back to the operating room.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Updates: (b)(4).Additional mfr narrative - added summary of investigation.Investigation summary: the affected product was not returned for physical examination and no photographs were provided.Complaint could only be confirmed through customer testimony.A review of the risk documents revealed that cuff detachment/separation is a known failure mode of this device and is being monitored and trended per the manufacturer's post-market surveillance processes.The device history record for this lot number was conducted and there is no evidence that a defective product was shipped, that the cuff was detached prior to shipment, or that this device was not manufactured to current specifications.A quality engineering risk assessment concluded that no risk reduction is necessary.A summary of the evaluation has been sent to the complainant.

• Brand Name: COOK-SWARTZ DOPPLER PROBE
• Type of Device: ITX TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 6945250
• MDR Text Key: 89282205
• Report Number: 2522007-2017-00029
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00827002213630
• UDI-Public: (01)00827002213630(17)200630(10)N148040
• 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: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: DP-SDP001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2017
• Initial Date FDA Received: 10/12/2017
• Supplement Dates Manufacturer Received: 09/15/2017
• Supplement Dates FDA Received: 02/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention