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

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

Product code: itx.(b)(4).This event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

A doppler crystal prematurely separated from the cuff and the patient had to go through an additional procedure to replace the doppler.

Manufacturer Narrative

Investigation summary: the complaint device was not returned and therefore a physical investigation could not be completed.The device history record was reviewed.There is no evidence that a defective product was manufactured.There are no signs that this cuff was detached prior to shipment or that this device was not manufactured to current specifications.Crystal epoxy separation is a known failure of this device.Capa 161942 was initiated to capture the correction activities of this failure.

• 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: 7472072
• MDR Text Key: 107197643
• Report Number: 2522007-2018-00014
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00827002213630
• UDI-Public: (01)00827002213630(17)200731(10)N148611
• Combination Product (y/n): N
• PMA/PMN Number: K022649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: DP-SDP001
• Device Lot Number: N148611
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention