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

Model Number	U4200330RX
Medical Device Problem Codes	Difficult to Remove (1528); Device-Device Incompatibility (2919); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one ultraverse rx pta dilatation catheter loaded onto an unknown guidewire has been received for the evaluation.On the visual evaluation, the device was noted to be bloody and no other specific anomalies were noted.On the functional evaluation, the attempt was made to remove guidewire from distal tip of the balloon was unsuccessful and another attempt was made to remove guidewire from the guidewire lumen encountered resistance, but was removed successfully.Then the guidewire lumen was flushed and the guidewire was attempted to be inserted but it was unsuccessful due to bunching on the inner guidewire lumen.Under the microscopic evaluation, the bunching was noted throughout the inner guidewire lumen and a kink was also noted at the proximal end of the balloon.No other functional testing was performed due to the condition of the returned device.Therefore the investigation was confirmed of the reported device-device incompatibility and difficult to advance as the guide wire couldn't able to advance into the catheter and the guide wire noted to stuck when returned for evaluation.Therefore the investigation for the identified difficult to remove was confirmed as the guide wire felt resistance during its removal from the guide wire lumen from the catheter.The investigation for the identified material deformation was confirmed as the bunching was noted on the inner guide wire lumen under the microscopic observation.A definitive root cause for the reported device-device incompatibility, difficult to advance, difficult to remove and material deformation could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.(expiry date: 10/2023).
Event or Problem Description
It was reported that prior to an angioplasty procedure, the device was allegedly difficult to advance before entering into the sheath.It was further reported that the device had incompatibility issue.The procedure was completed using another device.There was no patient contact.

• Brand Name: ULTRAVERSE RX
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12428426
• Report Number: 2020394-2021-01598
• Device Sequence Number: 3722944
• Product Code: LIT
• UDI-Device Identifier: 00801741057052
• UDI-Public: (01)00801741057052
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K131199
• 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
• Report Date (Section B): 08/11/2021

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: U4200330RX
• Device Catalogue Number: U4200330RX
• Device Lot Number: CMEY0100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 09/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1