MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 018; PTA BALLOON DILATATION CATHETER

Model Number	U87554
Medical Device Problem Codes	Leak/Splash (1354); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation for an angioplasty procedure via ipsilateral antegrade approach using 5fr sheath, the saline allegedly leaked from the hub during flushing.It was further reported that another device was used to complete the procedure.There was no patient contact.
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 018 pta dilatation catheter was returned for evaluation.During visual evaluation, no kinks were noted to the catheter shaft and no anomalies to the luers, or y-body.During functional testing, an in-house presto inflation device was used to inflate the balloon and water was noted leaking at the strain relief.The strain relief was cut and under microscopic examination, a pinhole tear was noted on the catheter shaft.No further functional testing was performed.Therefore, the investigation is confirmed for the reported leak and identified material torn as water was noted leaking at a pinhole tear on the catheter shaft during functional testing.A definitive root cause for the reported leak and identified material torn 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: 12/2023).

• Brand Name: ULTRAVERSE 018
• 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: 15571073
• Report Number: 2020394-2022-00788
• Device Sequence Number: 6180488
• Product Code: LIT
• UDI-Device Identifier: 00801741055119
• UDI-Public: (01)00801741055119
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121856
• 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): 09/14/2022

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: U87554
• Device Catalogue Number: U87554
• Device Lot Number: CMFN0418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 10/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 75 YR
• Patient Sex: Male
• Patient Weight: 60 KG