MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUE DILATATION CATHETER; VALVULOPLASTY BALLOON CATHETER

Catalog Number	0214512
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Blood Loss (2597); Vascular Dissection (3160)
Date of Event	04/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that during a tavr procedure, the valvuloplasty balloon allegedly ruptured and became lodged in the vessel.Surgical retrieval of the balloon was required and a vessel dissection repair of the left common iliac and abdominal aortic artery.There was no reported patient injury post surgical extraction.

• Brand Name: TRUE DILATATION CATHETER
• Common Device Name: VALVULOPLASTY BALLOON CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7559034
• Report Number: 2020394-2018-00771
• Device Sequence Number: 14062279
• Product Code: OZT
• UDI-Device Identifier: 00801741097447
• UDI-Public: (01)00801741097447
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/31/2018

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 Catalogue Number: 0214512
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 05/31/2018
• 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 Age: 82 YR