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)
Date of Event	01/01/2020
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 guide wire was used during a procedure to treat a severely tortuous, non calcified lesion exhibiting 100% stenosis in the distal right coronary artery (rca).There was no damage noted to the packaging.There was no issues removing the device from the packaging per ifu.The device was inspected with no issues noted.The wire tip was formed by the physician.The lesion was pre dilated.The device did not pass through a previously deployed stent.Resistance was not encountered.Excessive force was not used during delivery.It was reported that the patient was stemi and the physician felt the wire wasn't steering well and when the device was removed the wire was unraveled.The patient is alive with no injury.
Additional Manufacturer Narrative
The patient presented in the cath lab with stemi.A femoral approach was used.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis #249616533:one still image was received for analysis.The image shows the coil stretched and unraveled from the distal end.From the image provided, it cannot be confirmed whether there is any other deformation to the wire.Product analysis #250958322: one device returned coiled up in plastic bag in opened inner pouch.Lot# g19a04564 on pouch.One 0.014¿ guidewire was received.Visual inspection of this wire revealed the returned wire was not a cougar device.The wire had positioning markers, which are not characteristic of the cougar guidewire.Several joints which are characteristic of the cougar guidewire were not present on the returned wire.This was confirmed by sme's of the cougar guidewire.A thorough analysis will not be carried out on this device as it a non-medtronic product.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• 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: 9564105
• Report Number: 1220452-2020-00004
• Device Sequence Number: 16860456
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2020

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: 01/06/2020
• Supplement Date Received by Manufacturer: 01/08/2020; 02/27/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 01/15/2020; 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 98