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

Model Number	U3575610
Medical Device Problem Codes	Retraction Problem (1536); Material Rupture (1546); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer.Two photos of the device and packaging were provided.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 balloon allegedly had difficulty being retracted through the sheath.The malfunctioned device was removed and the procedure was successfully completed with the use of another device.There was no reported patient injury.
Additional Manufacturer Narrative
The device history records have been reviewed and 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.The device and two photos were returned for evaluation.Based on the photo review no failures were able to be confirmed.The visual inspection identified the catheter had stretching, the distal tip was deformed and the balloon had a compound rupture.The stretching noted is also associated with retraction issues.Functional testing was not viable due to the balloon rupture.Therefore, the investigation is confirmed for material deformation, balloon rupture and retraction issues.It is unknown how the balloon became ruptured, however it is likely the rupture resulted in the retraction issues and therefore catheter stretching.However, the definitive root cause for the reported deflation issue or identified rupture could not be determined based on the available information.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 an angioplasty procedure, the pta balloon allegedly had difficulty being retracted through the sheath.The malfunctioned device was removed and the procedure was successfully completed with the use of another device.There was no reported patient injury.

• Brand Name: ULTRAVERSE 035 PTA 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: 7592347
• Report Number: 2020394-2018-00847
• Device Sequence Number: 1813524
• Product Code: LIT
• UDI-Device Identifier: 00801741092985
• UDI-Public: (01)00801741092985
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2018

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: 11/30/2020
• Device Model Number: U3575610
• Device Catalogue Number: U3575610
• Device Lot Number: CMBZ0348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 08/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1