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

Catalog Number	CGRXT190HJ
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use a cougar guidewire to treat a moderately tortuous, severely calcified lesion in the mid lad.There was no damage noted to packaging.The device was removed from packaging per ifu with no issues.The device was inspected and prepped per ifu with no issues.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Excessive force was not used during delivery.It is reported that when the physician went to extract the device from the patient it began to unravel.There was no resistance when the physician was extracting the wire.No portion of the wire remains in the patient, which was confirmed through fluoroscopy.There is no patient injury is reported.
Additional Manufacturer Narrative
Product analysis summary: the guide wire was received severely stretched and unraveled.On closer visual inspection, the core wire was found to be broken, the break was noted 26.2cm from the distal hypo tube and core wire joint.The broken core coil wire was noted broken near the first joint.The proximal portion of the ribbon remained engaged to the distal tip of the wire.The unraveling, break and stretched coils resulted in the ribbon detaching from the core wire.One unbroken coil wire was detected holding the whole length of the wire as one piece.No sections of the wire were missing.Actual measurements taken on the cougar wire were within product performance requirement maximum at joints, along spring, coated core wire (distal section of the distal tip was not damaged), and hypo tube.If information is provided in the future, a supplemental report will be issued.

• Brand Name: COUGAR GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 7047864
• Report Number: 1220452-2017-00118
• Device Sequence Number: 11042617
• Product Code: DQX
• UDI-Device Identifier: 20643169452828
• UDI-Public: 20643169452828
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K140695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2018

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 Expiration Date: 08/09/2020
• Device Catalogue Number: CGRXT190HJ
• Device Lot Number: G17A04956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Initial Date Received by Manufacturer: 10/24/2017
• Supplement Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 03/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 84