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

Catalog Number	U35130310
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/27/2017
Type of Reportable Event	Malfunction
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.Visual inspection: the sample was returned with the product label.The balloon size for this product was printed on the balloon hub of the catheter and identified the returned sample as a 3.0mm x 100mm balloon.A circumferential balloon rupture was present 0.8cm from the distal tip.No other anomalies were noted along the length of the catheter.Functional/performance evaluation: functional testing could not be performed due to the condition in which the sample was received.Medical records review: medical records were not provided for review.Image/photo review: images/photos were not provided for review.Conclusion: a manufacturing review was conducted.The lot met all release criteria.The device was returned.The investigation was confirmed for a circumferential balloon rupture based on the condition of the returned sample.The definitive root cause could not be determined based upon available information.It was unknown whether patient and/or procedural issues contributed to the event.Labeling review: the current ifu (instructions for use) states: warnings: do not exceed the rated burst pressure (rbp) recommended for this device.Balloon rupture may occur if the rbp rating is exceeded.To prevent over pressurization, use of a pressure monitoring device is recommended.Precautions: if resistance is still felt during post procedure withdrawal of the catheter, it is recommended to remove the balloon catheter and introducer sheath/guide catheter s a single unit.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.Potential adverse reactions: additional intervention.(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 the pta balloon ruptured (below nominal pressure) during the first inflation in the distal region of the popliteal artery.The balloon catheter was exchanged over the guidewire 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: 6423265
• Report Number: 2020394-2017-00232
• Device Sequence Number: 552877
• Product Code: LIT
• UDI-Device Identifier: 00801741091704
• UDI-Public: (01)00801741091704(17)180525(10)50124228
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K142261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/21/2017

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: 05/25/2018
• Device Catalogue Number: U35130310
• Device Lot Number: 50124228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2017
• Initial Report FDA Received Date: 03/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 63