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

Catalog Number	CGRXT190HS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A cougar guidewire was intended to be used during a procedure for a lesion located in the mid lad, exhibiting no tortuosity, mild calcification and 100% stenosis.No damage noted to packaging.No issues noted when removing device from packaging as per ifu.Device was inspected and prepped per ifu without issue.Device tip was formed by the physician.The lesion was pre-dilated.The device did not pass through a previously deployed stent.No resistance was felt and excessive force was not used.It is reported that the device detached in vivo.The very tip of the wire came off and was trapped between the vessel wall and stent.No patient injury reported.
Additional Manufacturer Narrative
Additional information received reported that a stent was placed in the lad lesion and the physician advanced a second cougar into a diagonal branch to protect the vessel.After stent deployment the physician attempted to remove the diagonal wire and the very tip of the wire came off and was trapped between the vessel wall and stent.The wire was unable to be removed and remains trapped between the stent and the intimal lining.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: the wire exhibited damage to coils 2cm and 5mm proximal to the first joint, it appears that the wire was torqued resulting in damage to the distal coils.The coils bunched up proximal to the first joint.The distal tip is missing.The coil wire distal tip is stretched, and the inner core and ribbon wire exposed.Close visual inspection under magnification detected the ribbon normally glued to the core wire.The inspection detected a broken coil wire and broken distal ribbon, some twisting was noted to the ribbon.The full length of the wire returned measured 190cm, although the tip ball was missing.Cine analysis: cine review indicates that the tip of the guide wire became entangled with the stent.Upon removal of the guide wire the radiopaque tip coil portion of the guide wire was separated from the guide wire core.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: 7901566
• Report Number: 1220452-2018-00111
• Device Sequence Number: 1552585
• Product Code: DQX
• UDI-Device Identifier: 00643169453326
• UDI-Public: 00643169453326
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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,Followup
• Report Date (Section B): 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/03/2021
• Device Catalogue Number: CGRXT190HS
• Device Lot Number: G18A06956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 10/19/2018; 02/15/2019
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 10/31/2018; 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 94