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

Catalog Number	CGRLS190HS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/23/2019
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 guide wire was used during a procedure to treat a mildly calcified lesion in the mid right coronary artery (rca).There was no damage noted to the packaging.There was no issues noted when removing the device from the packaging.The device was inspected and prepped per ifu with no issues noted.The wire tip was formed by the physician.The lesion was pre-dilated.Resistance was not encountered and excessive force was not used during the procedure.It was reported that a detachment occurred on the cougar during removal.Another wire was wrapped around the detached portion and pulled it into the guide catheter for removal.No further patient injury reported.One wire was returned for evaluation.Packaging from lot g19a05977 and from lot g19a06774 was also returned.It was reported that multiple cougars were opened during the procedure, and it could not be determined which packaging the detached wire was from.(pli20 added for lot g19a06774).

• 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: 9368360
• Report Number: 1220452-2019-00147
• Device Sequence Number: 2224520
• Product Code: DQX
• UDI-Device Identifier: 00643169453319
• UDI-Public: 00643169453319
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 11/25/2019

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: 07/11/2022
• Device Catalogue Number: CGRLS190HS
• Device Lot Number: G19A06774
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 11/25/2019
• 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