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

Model Number	N/A
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
It was reported that the device detached from the cuff prematurely, requiring an additional procedure to replace the device.No additional consequences to the patient were reported.
Additional Manufacturer Narrative
Investigation summary: the affected product was returned for this complaint.The device was inspected under magnification, and there is epoxy on one side of the crystal.There was no epoxy remaining on the opposite side of the crystal.The cuff was returned separated from the wire.Visual inspection of the device confirmed the customer's complaint.A functional test was performed on the probe and the audible pulse signal was verified on both sides of the crystal.No other nonconformities or anomalies were observed on the device.A device history record review was conducted, which revealed no signs that this cuff was detached prior to shipment or that this device was not manufactured to current specifications.

• Brand Name: COOK-SWARTZ DOPPLER PROBE
• Common Device Name: DIAGNOSTIC ULTRASONIC TRANSDUCER
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 7330226
• Report Number: 2522007-2018-00007
• Device Sequence Number: 13516974
• Product Code: ITX
• UDI-Device Identifier: 00827002213630
• UDI-Public: (01)00827002213630(17)200731(10)N148616
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: DP-SDP001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 03/12/2018
• Supplement Report FDA Received Date: 05/21/2018
• 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