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

Model Number	GWBC30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Left Ventricular Hypertrophy (1949); Cardiac Perforation (2513)
Date of Event	06/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned, therefore no product analysis can be performed.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 prior to the implant of this transcatheter bioprosthetic valve, the guidewire perforated the left ventricle during the pre-balloon aortic valvuloplasty (bav).The patient recovered with cardiopulmonary resuscitation (cpr) and a pericardial drain was performed.The valve was implanted successfully and a post bav was performed.No further adverse patient effects were reported.
Additional Manufacturer Narrative
Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.The physician reported that there was no defect with the guidewire and that the event was related to patient anatomy.The left ventricle was reported as being very hypertrophic and the physician stated that this event could have occurred with any manufacturers guidewire.The patient's anatomy played a major role in the reported perforation.Unfortunately, without angiography or further information such as a returned unit, medtronic is unable to conclusively asses the condition of the guidewire for defects.Based on this information, this event does not indicate device misuse or malfunction.

• 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: 6712087
• Report Number: 2025587-2017-01164
• Device Sequence Number: 13854213
• Product Code: DQX
• UDI-Device Identifier: 20643169583737
• UDI-Public: 20643169583737
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 08/04/2017

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: 01/31/2019
• Device Model Number: GWBC30
• Device Catalogue Number: GWBC30
• Device Lot Number: 91505208
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2017
• Supplement Date Received by Manufacturer: 08/04/2017
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 08/21/2017
• 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: Required Intervention