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

Model Number	U41502H22
Medical Device Problem Codes	Leak/Splash (1354); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2021
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 014 pta dilatation catheter has returned into two segments for evaluation.On the visual evaluation of the returned segments, the first segment contains the catheter shaft and the y-body and the segment consist of balloon part which noted stuck within the balloon protector and stylet, the stylet was removed from the distal tip of the balloon and the balloon protector was made a cut to remove the balloon, it was further noted that the proximal marker band was noted to dislodge and not returned for evaluation.No other anomalies noted.All the anomalies noted on the microscopic observation.No further testing performed due to the condition of the device.Therefore, the investigation for reported leak remains inconclusive as no functional evaluation couldn¿t be performed due condition of the device.The investigation was confirmed the identified balloon detachment as the returned device noted to be detached into two segments.The investigation was also confirmed for balloon marker band dislodge as the proximal marker band noted to be dislodge from the balloon and not returned for evaluation.A definitive root cause for the reported leak, identified balloon detachment, balloon marker band dislodge 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).
Event or Problem Description
It was reported that during an angioplasty procedure, the device allegedly had a leak.The procedure was completed by using another device.There was no reported patient injury.

• Brand Name: ULTRAVERSE 014 PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12679201
• Report Number: 2020394-2021-01898
• Device Sequence Number: 1206394
• Product Code: LIT
• UDI-Device Identifier: 00801741053658
• UDI-Public: (01)00801741053658
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/05/2021

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: U41502H22
• Device Catalogue Number: U41502H22
• Device Lot Number: CMFN0031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR