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

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 02/07/2018

Event Type  Injury  

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 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.

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
• Type of Device: DIAGNOSTIC ULTRASONIC TRANSDUCER
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer Contact: brian johnston ; 1186 montgomery lane; vandergrift, PA 15690 ; 4128458621
• MDR Report Key: 7330226
• MDR Text Key: 102212599
• Report Number: 2522007-2018-00007
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00827002213630
• UDI-Public: (01)00827002213630(17)200731(10)N148616
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K022649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: DP-SDP001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention