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

Catalog Number	U4150310RX
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.H11: section a: through f: the information provided by bd 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 bd.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly had hole.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: 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.Investigation summary: one ultraverse rx dilatation catheter was received for evaluation.During visual analysis no other anomalies were noted.On functional testing an in-house inflation device used for inflation and could observe leak in catheter shaft near to distal tip side.Further the leaked part underwent to the microscopic analysis and could observe a tear.No further testing was performed due to condition of device.Based on the return sample analysis leak and tear in the catheter shaft could be identified and due to the device condition further testing for balloon rupture was not performed.Hence the investigation was confirmed for the identified leak and tear in catheter shaft, and was inconclusive for the reported balloon rupture.During the microscopic observation a tear in catheter was observed which might lead to the identified leak.However the definitive root cause for the identified leak, tear in catheter shaft and reported balloon rupture issues could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly had a hole.There was no reported patient injury.

• 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
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18765499
• Report Number: 2020394-2024-00251
• Device Sequence Number: 7627590
• Product Code: LIT
• UDI-Device Identifier: 00801741056895
• UDI-Public: (01)00801741056895
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2024

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 Catalogue Number: U4150310RX
• Device Lot Number: CMGU0338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown