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

Catalog Number	U357554
Medical Device Problem Codes	Retraction Problem (1536); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.The lot met all release criteria.Visual/microscopic inspection: the sample was bloody.The balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as a 5mm x 40mm balloon.A circumferential balloon rupture was present 4.4cm from the distal tip.The distal portion of the balloon was still attached to the catheter and was bunched in appearance and prolapsed over the distal tip, likely indicating retraction issues.The balloon rupture was examined under microscopic magnification (10x) and the edges were uneven, indicating that the rupture was not clean.The inner guidewire lumen was stretched and the distal marker band was dislodged from its original locations, likely indicating that excessive force contributed to the event.No other anomalies were noted along the length of the catheter.The introducer sheath tip was examined under microscopic magnification (12.5x) and was observed to be flared, likely indicating retraction issues.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; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the device was returned within a 6fr introducer sheath.The investigation is confirmed for a circumferential balloon rupture and retractions issues based on the condition of the returned sample (i.E.Balloon sheared in half and prolapsed over the distal tip).Per the reported event details, the balloon ruptured at 18atm.The rated burst pressure (rbp) for this balloon size is 17atm; therefore, the balloon was overpressurized.The current ifu (instructions for use) states "do not exceed the 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." it is likely that the balloon ruptured as a result of being overpressurized.The root cause for this event is most likely use-related.Labeling review: the current ultraverse 035 pta balloon catheter instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.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, the pta allegedly ruptured at 18 atm.It was further reported that the health care provider (hcp) had difficulty retracting the balloon through the sheath.Reportedly, the hcp had to enlarge the access site in order to remove the balloon and sheath together as one unit.No further treatment was provided.There was no reported patient injury.

• Brand Name: ULTRAVERSE 035 PTA CATHETER
• Common Device Name: PTA DILATATION BALLOON CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 5723466
• Report Number: 2020394-2016-00548
• Device Sequence Number: 103526
• Product Code: LIT
• UDI-Device Identifier: 00801741092459
• UDI-Public: (01)00801741092459(17)190331(10)50137055
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K142261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/18/2016

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: U357554
• Device Lot Number: 50137055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2016
• Initial Report FDA Received Date: 06/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR