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

Catalog Number	U35130104
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure via left subclavian artery, the pressure could not be increased while dilation.It was further reported in inspection that after removal, the balloon leaked air.Reportedly, a balloon replacement could be inflated properly, and the procedure was completed successfully.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 035 pta dilatation catheter was returned for evaluation.No specific anomalies were noted during the visual evaluation.On the functional testing, the balloon catheter was inflated with the in-house presto inflation device, during which the balloon was leaking from the balloon.Under microscopic compound rupture was observed.No functional testing was performed.One photo was received and reviewed.The balloon was noted to be in deflated condition and appeared to be bloody.No objective evidence of balloon rupture can be noted.No other specific anomalies.One video was received and reviewed.The balloon was noted to be connected with an unknown syringe and the balloon had been inflated.Water was noted to be leaking from the balloon.However, the source of the leak is unknown and can¿t be noted in the submitted video.As the submitted photo doesn¿t provide the significant evidence of rupture, and the submitted video confirms the evidence of leak but the source of leak is unknown.However, during the sample analysis, a compound rupture was noted during microscopic observation, hence the investigation was confirmed for the reported balloon rupture.A definitive root cause for the reported balloon rupture 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.H10: d4 (expiration date: 06/2025).H11: section a through f ¿ the information provided by bd represents all 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.H3 other text : see h10.

• Brand Name: ULTRAVERSE 035
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 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: 18129995
• Report Number: 2020394-2023-01038
• Device Sequence Number: 6439620
• Product Code: LIT
• UDI-Device Identifier: 00801741094705
• UDI-Public: (01)00801741094705
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K142261
• 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
• Report Date (Section B): 11/02/2023

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: U35130104
• Device Lot Number: CMGU0071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2022
• 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