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

Model Number	CGRXT190HS
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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
A cougar guidewire device was being used to treat a mammary graft in the distal left anterior descending artery.The lesion was moderately tortuous, moderately calcified with 95% stenosis.No damage was noted to the packaging and no issues were noted to the device when removing from the packaging per the ifu.The device was inspected and prepped per the ifu with no issues noted.The wire tip was formed by the physician.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during insertion and delivery.It was reported that the lad was wired through a lima graft with the cougar xt 190cm wire inside a non medtronic microcatheter.Resistance was felt when wiring the vessel and it was felt that the wire was starting to uncoil at that point.As the cougar wire was being removed resistance was encountered.The wire was removed safely from the patient however it was observed that the wire started to uncoil.The uncoiling occurred when the device was in the patient.The coils became stretched.There was no fracture of the coil.There was not a complete detachment of the wire.No patient injury was reported.
Additional Manufacturer Narrative
Product analysis: one still image was received for analysis of a coiled-up guidewire on the device packaging.Lot number: g19a04564 and device information on the packaging matches details in the complaint file.The wire appears to have unraveled from the distal end.The coils appear stretched.It cannot be confirmed from the image provided whether there is any other deformation to the wire.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: 9705038
• Report Number: 1220452-2020-00019
• Device Sequence Number: 3675529
• Product Code: DQX
• UDI-Device Identifier: 00643169453326
• UDI-Public: 00643169453326
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

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: 05/09/2022
• Device Model Number: CGRXT190HS
• Device Catalogue Number: CGRXT190HS
• Device Lot Number: G19A04564
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1