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

Model Number	N/A
Medical Device Problem Codes	Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/13/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: ITX TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 6945250
• Report Number: 2522007-2017-00029
• Device Sequence Number: 891596
• Product Code: ITX
• UDI-Device Identifier: 00827002213630
• UDI-Public: (01)00827002213630(17)200630(10)N148040
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K022649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: DP-SDP001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 10/12/2017
• Supplement Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention