MAUDE Adverse Event Report: MEDTRONIC, INC COUGAR GUIDE WIRE; WIRE, GUIDE, CATHETER

Catalog Number CGRXT190HS

Device Problem Material Distortion (2977)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2017

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the guide wire exhibited two stretched sections.The stretched coils were noted approximately 3cm and 1.5cm from the distal tip ball.The distal tip ball was intact.No other damage was noted to the guide wire.Physical measurements show the device meets specification.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician intended to use a cougar guide wire during a procedure.No damage was noted to the device packaging and no issues noted when removing the wire from the hoop.The wire was inspected and prepped per ifu with no issues noted.Damage was noted to the wire on removal from the patient.Analysis of the returned wire identified stretched coils.

• Brand Name: COUGAR GUIDE WIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6642795
• MDR Text Key: 77621983
• Report Number: 1220452-2017-00056
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 20643169453320
• UDI-Public: 20643169453320
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2019
• Device Catalogue Number: CGRXT190HS
• Device Lot Number: G16A06130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2016
• 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