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

Catalog Number	TF0183511
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records were provided to the manufacturer.An image was provided.The lot number for the device was provided.The device history records and image are currently under review.The device was not returned to the manufacturer for evaluation.The investigation is currently under way.
Event or Problem Description
It was reported that during an aortic valvuloplasty procedure, the balloon valvuloplasty catheter allegedly got caught on the guidewire during advancement.It was further reported that after significant resistance the balloon valvuloplasty catheter was exchanged over the guidewire for another and the procedure was successfully completed.There was no patient contact.
Event or Problem Description
It was reported that during an aortic valvuloplasty procedure, the balloon valvuloplasty catheter allegedly got caught on the guidewire during advancement.It was further reported that after significant resistance the balloon valvuloplasty catheter was exchanged over the guidewire for another and the procedure was successfully completed.There was no patient contact.
Additional Manufacturer Narrative
The device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.The investigation is inconclusive, as the sample was not returned for evaluation.The root cause could not be determined based upon available information.It is unknown whether procedural issues contributed to the event.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H11:section a through f - the information provided by bd 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 bd.

• Brand Name: TRUE FLOW DILATATION CATHETER
• Common Device Name: BALLOON VALVULOPLASTY CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8118514
• Report Number: 2020394-2018-02141
• Device Sequence Number: 1710676
• Product Code: OZT
• UDI-Device Identifier: 00801741097645
• UDI-Public: (01)00801741097645
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172932
• 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
• Report Date (Section B): 01/16/2019

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: 05/28/2017
• Device Catalogue Number: TF0183511
• Device Lot Number: GFAS2140
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/11/2016
• Supplement Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1