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

Model Number	N/A
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2018
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
It was reported that an atain abiltiy plus lead and a cougar guide wire were used during a procedure in the left main coronary artery, exhibiting no tortuousity and no calcification.No damage noted to packaging, no issues removing the device from packaging as per ifu.The cougar was inspected with no issues, but was not prepped per ifu.The cougar was flushed before using.The wire tip was formed a little by the physician.The lesion was not pre-dilated, the device did not pass through a previously deployed stent.Excessive force was not used during delivery.It is reported that some resistance was experienced when putting the lead over the wire, during use and during removal.The lead was completely explanted - the cougar wire could not be removed from the lead body.No injury reported.
Additional Manufacturer Narrative
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: 8682784
• Report Number: 1220452-2019-00073
• Device Sequence Number: 19333779
• Product Code: DQX
• UDI-Device Identifier: 20643169452804
• UDI-Public: 20643169452804
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K140695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2019

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: 12/20/2020
• Device Model Number: N/A
• Device Catalogue Number: CGRXT190S
• Device Lot Number: G17A10194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1