MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CONFIDA BRECKER CURVE GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	GWBC30
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Death (1802); Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513)
Date of Event	07/14/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Product analysis: the product was discarded by the customer and will not been returned for analysis.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
Medtronic received information that during the implant of a transcatheter bioprosthetic valve, a left ventricle perforation was note d at the apex during valve deployment.Since the blood pressure decreased and was not recovering, the valve was pulled up into the ascending aorta to stabilize the patient.Cardiopulmonary resuscitation (cpr) was performed and anesthesia support was provided but the patient subsequently expired due to the perforation.Per the physician, the perforation was caused by the medtronic guidewire.No autopsy was performed.
Additional Manufacturer Narrative
Additional information was received that the guidewire was inspected prior to use and appeared to be in good condition.The guidewire was introduced into the ventricle through a catheter that was already positioned in the ventricle.No unusual resistance was felt.The physician did not believe that a malfunction of the device caused this event.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: CONFIDA BRECKER CURVE GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6768076
• Report Number: 2025587-2017-01304
• Device Sequence Number: 11135607
• Product Code: DQX
• UDI-Device Identifier: 20643169583737
• UDI-Public: 20643169583737
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K132623
• 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
• Report Date (Section B): 08/10/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: GWBC30
• Device Catalogue Number: GWBC30
• Device Lot Number: 91605107
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/14/2017
• Supplement Date Received by Manufacturer: 08/10/2017
• Initial Report FDA Received Date: 08/04/2017
• Supplement Report FDA Received Date: 08/10/2017
• 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: Death
• Patient Age: 88 YR
• Patient Weight: 72