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

Catalog Number	CGRLS190HJ
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It is reported that a cougar guide wire ruptured inside an attain lead during a lead placement procedure.The lead was being placed in the cs, post lat vein.The vessel was mildly tortuous with no calcification.The lesion was not pre-dilated.It was reported that a new attain lead was used.No damage was noted to packaging of the cougar wire.The wire was inspected with no issues.The device was not prepped per ifu.The wire tip was not formed by the physician.The wire did not pass through a previously-deployed stent.Resistance was not encountered when advancing the wire, and excessive force was not used.The wire detached during removal.All portions of the cougar wire successfully removed from the patient.The wire was removed with the lead.One portion is inside the lead.The lead was removed.The patient was hospitalized as a result of the event but the patient status is reported as alive - no injury.
Additional Manufacturer Narrative
Detachment confirmed on (b)(6) 2017.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: the wire was stretched and broken at the distal end, with both bonds intact.The wire was stretched in a distal direction indicating the distal tip was caught and the wire was pulled.The distal end of the guide wire was bent at a 90-degree angle, and the tip of the wire was missing.The end of the core and ribbon wires length from the distal bond, indicated that the 2mm solder tip and a portion of the coil wire was missing and not returned, reportedly still in the attain lead used during the procedure.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: 6680845
• Report Number: 1220452-2017-00062
• Device Sequence Number: 187820
• Product Code: DQX
• UDI-Device Identifier: 20643169452897
• UDI-Public: 20643169452897
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K032899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/06/2017

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: 01/07/2019
• Device Catalogue Number: CGRLS190HJ
• Device Lot Number: G16A00088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Initial Date Received by Manufacturer: 06/02/2017
• Supplement Date Received by Manufacturer: 06/02/2017; 06/02/2017; 10/09/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 06/30/2017; 09/07/2017; 11/06/2017
• 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: Hospitalization
• Patient Age: 56 YR