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

Model Number	CGRXT190HS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Injury (2348); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Date of Event	10/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
One cougar guide wire was attempted to be used during a procedure to treat a non-tortuous lesion in the proximal lad.There was no damage noted to the device packaging.There were no issues noted to the device during removal from the packaging.The device was inspected with no issues noted.The device was prepped per ifu with no issues.The wire tip was formed by the physician.An ebu 4.5 guide catheter was also used.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device and excessive force was not used.It was reported that the wire tip detached while in the patient.After stenting the lad, the physician went to withdraw the wire and noticed that the tip had broken off.The physician then re-wired the vessel and jailed the detached segment against vessel wall in the lad with another stent.No further patient injury reported.
Additional Manufacturer Narrative
Product analysis #704016950:one cougar guidewire was received for analysis.The coils were stretched, severely entangled and unraveled.The proximal bond stretched in a distal direction.The tip had detached.A kink was noted on the guidewire approx.44cm from the proximal end of the wire.No other damage was noted to the remainder of the device.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.
Additional Manufacturer Narrative
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: 10703700
• Report Number: 1220452-2020-00084
• Device Sequence Number: 17051519
• Product Code: DQX
• UDI-Device Identifier: 00643169453326
• UDI-Public: 00643169453326
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K140695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/13/2023
• Device Model Number: CGRXT190HS
• Device Catalogue Number: CGRXT190HS
• Device Lot Number: G20A03635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 12/07/2020; 01/20/2021
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 12/16/2020; 01/22/2021
• 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: Required Intervention
• Patient Weight: 99