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

Model Number	0204511
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the device is pending.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that during preparation for a valvuloplasty procedure, the ptv balloon allegedly had a leak at the inflation hub.Another device was used to perform the procedure.There was no reported patient involvement.
Additional Manufacturer Narrative
Manufacturing review: 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.Investigation summary: the device was returned.A visual inspection found a partial circumferential shaft break under the strain relief at the distal end of the bifurcate.Functional testing was conducted and upon inflation, water was observed leaking at the break.Therefore, the investigation is confirmed for a break in the catheter shaft and the reported leak.The break in the outer shaft would have resulted in the reported leak.However, the definitive root cause for the break 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.
Event or Problem Description
It was reported that during preparation for a valvuloplasty procedure, the ptv balloon allegedly had a leak at the inflation hub.Another device was used to perform the procedure.There was no reported patient involvement.

• Brand Name: TRUE FLOW PTV 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: 8182338
• Report Number: 2020394-2018-02229
• Device Sequence Number: 1620357
• Product Code: OZT
• UDI-Device Identifier: 00801741090998
• UDI-Public: (01)00801741090998
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K150667
• 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): 03/22/2019

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 Model Number: 0204511
• Device Catalogue Number: 0204511
• Device Lot Number: GFBN1147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1