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

Model Number	LVCLS190J
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the guidewire was returned and analyzed.The analysis indicated that the stylet/guidewire was broken.The guidewire was unraveled.Visual analysis of the guidewire indicated damage during use.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during left ventricular (lv) lead implant the guidewire became stuck and subsequently broke inside the lead.The lead was not used and will not be replaced in the future.No patient complications have been reported as a result of this event.

• Brand Name: COUGAR LS
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 9041646
• Report Number: 1220452-2019-00125
• Device Sequence Number: 14058529
• Product Code: DQX
• UDI-Device Identifier: 00643169453272
• UDI-Public: 00643169453272
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 09/13/2019

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: 11/08/2021
• Device Model Number: LVCLS190J
• Device Catalogue Number: LVCLS190J
• Device Lot Number: G18A11446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR