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

Model Number	LVCXT190J
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the implant procedure, the guidewire became stuck in the left ventricular (lv) lead and seemed to wrap itself back into the insulation of the lv lead.The guidewire started to unravel and the lv lead exhibited insulation damage.The lv lead and guidewire were replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the analysis confirmed the guide wire was returned in two pieces with the distal end of the wire stuck in the lead and the wire was stretched and pulled apart at the proximal end of the lead.The remaining proximal portion of the wire is coil wrapped.There was also visible damage to the tip lead.If information is provided in the future, a supplemental report will be issued.

• Brand Name: COUGAR XT
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 6781679
• Report Number: 1220452-2017-00073
• Device Sequence Number: 19082542
• Product Code: DQX
• UDI-Device Identifier: 20643169453290
• UDI-Public: 20643169453290
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K032899
• 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): 02/08/2018

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: 02/23/2019
• Device Model Number: LVCXT190J
• Device Catalogue Number: LVCXT190J
• Device Lot Number: G16A01804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Initial Date Received by Manufacturer: 06/19/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR