MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA BALLOON DILATATION CATHETER

Catalog Number	U357544
Medical Device Problem Codes	Break (1069); Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to material review reports, manufacturing process, and quality control inspection.This lot met all release criteria.The product history for the device was also reviewed.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.Visual/microscopic inspection: the sample was returned.The balloon size for this product was printed on the balloon hub of the catheter and identified the returned sample as a 4.0mm x 40mm balloon.The balloon was examined under magnification and a break in the catheter was noted 4.5cm from the distal tip, between the proximal marker and the inflation/deflation port.As the balloon was obstructing the break, the balloon was cut away from the catheter, and the break was found to be a complete circumferential break.No anomalies were noted to the strain relief or the y-hub.Functional/performance evaluation: functional testing was not conducted based on the condition of the returned sample.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the investigation was confirmed for a break.However, the investigation was inconclusive for the reported inflation issue, as the device was not able to be inflated due to the returned sample condition (e.G.Break in the catheter).The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: the current ifu (instructions for use) states: precautions: carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape, and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.Use of the ultraverse 035 pta dilatation catheter: position the balloon relative to the lesion to be dilated, ensure the guidewire is in place, and inflate the balloon to the appropriate pressure.(b)(4).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 an angioplasty procedure to treat the sfa, the pta balloon allegedly would not inflate during the first inflation.There was no reported difficulty in retracting the balloon through the introducer sheath.Reportedly, the pta balloon was exchanged for another and the procedure was completed.There was no reported patient injury.

• Brand Name: ULTRAVERSE 035 PTA BALLOON DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6513552
• Report Number: 2020394-2017-00357
• Device Sequence Number: 91677
• Product Code: LIT
• UDI-Device Identifier: 00801741091957
• UDI-Public: (01)00801741091957(17)190331(10)50137164
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K142261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 04/21/2017

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: 03/31/2019
• Device Catalogue Number: U357544
• Device Lot Number: 50137164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2017
• Initial Report FDA Received Date: 04/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 74