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	Patient Problem/Medical Problem (2688)
Date of Event	12/29/2018
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 wire was attempted to be used to treat a calcified lesion with 90% stenosis in the mid lad.There was no damage noted to the device packaging.The device was removed from the packaging per ifu with no issues.The device was inspected with no issues noted.The device was prepped per ifu.The wire tip was formed by the physician.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device and excessive force was not used.It is reported that the tip of the device detached after pci.The patient went to surgery to remove the detached portion.No further patient injury reported.
Additional Manufacturer Narrative
Image review: analysis of two images indicates the presence of what appears a distal section of the radiopaque wire.One of the images also shows what appears to be a lead.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: 8216554
• Report Number: 1220452-2019-00001
• Device Sequence Number: 19240286
• Product Code: DQX
• UDI-Device Identifier: 00643169453326
• UDI-Public: 00643169453326
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/11/2019

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: 09/02/2021
• Device Catalogue Number: CGRXT190HS
• Device Lot Number: G18A09275
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/29/2018
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention