MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014; PTA BALLOON DILATATION CATHETER

Model Number	U4150322
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 014 pta dilatation catheter was returned for evaluation.No specific anomalies were noted during the visual evaluation.On the functional testing, the returned catheter was inflated with an in-house presto inflation device and water was leaking from the strain relief.Furthermore, the strain relief was removed, and the catheter was inflated once again, and the water was leaking from the two holes proximal to the y-body.Under microscopic observation, it was noted that glue was noted to not be fully intact.A kink was also noted in the catheter shaft under strain relief.No other functional testing was performed.Two photos were reviewed.Both show the catheter and balloon in a coiled up position.No specific anomalies could be noted.A mark was made by the user near the strain relief in the second photos.However, evidence of leakage was not able to be observed from the submitted photos.Based on the submitted photos, no evidence of the reported leak could be observed.However, based on the sample evaluation of the returned device, the investigation for the reported leak was confirmed as water was leaking from the strain relief upon inflation during the functional testing.The investigation was also confirmed for the identified break as the water was noted to be leaking from the holes present in the y-body where the glue was not fully intact.During the microscopic observation, a break on the proximal y-body might have led to the reported leak.A definitive root cause could not be determined based upon the available 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: 08/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon allegedly had a leak in the connection of the shaft with the inflation port.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: ULTRAVERSE 014
• 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: 15657013
• Report Number: 2020394-2022-00833
• Device Sequence Number: 12229496
• Product Code: LIT
• UDI-Device Identifier: 00801741053832
• UDI-Public: (01)00801741053832
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 09/28/2022

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: U4150322
• Device Catalogue Number: U4150322
• Device Lot Number: CMEW0359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2020
• 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