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

Catalog Number	TF0203511
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device was returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that during preparation for a valvuloplasty procedure, the balloon valvuloplasty catheter allegedly would not thread onto the guidewire.It was further reported that the balloon valvuloplasty catheter was exchanged over the guidewire for another and the procedure was successfully performed.There was no patient contact.
Event or Problem Description
It was reported that during preparation for a valvuloplasty procedure, the balloon valvuloplasty catheter allegedly would not thread onto the guidewire.It was further reported that the balloon valvuloplasty catheter was exchanged over the guidewire for another and the procedure was successfully performed.There was no patient contact.
Additional Manufacturer Narrative
Manufacturing review: the device history records were 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 event reported to date for this lot number and failure mode.Investigation summary: the device was returned.The investigation is confirmed for device-device incompatibility, as an in-house guidewire encountered some resistance passing through the distal tip.The root cause could not be determined based upon available information.It is unknown whether procedural issues contributed to the event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

• 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: 8118554
• Report Number: 2020394-2018-02140
• Device Sequence Number: 19246706
• Product Code: OZT
• UDI-Device Identifier: 00801741097652
• UDI-Public: (01)00801741097652
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/15/2019

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: 06/28/2017
• Device Catalogue Number: TF0203511
• Device Lot Number: GFAU0053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Initial Date Received by Manufacturer: 10/27/2016
• Supplement Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1