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

Model Number	VA8094
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon was allegedly ruptured and detached and a piece of it was left in the stent.It was further reported that it was not able to be retrieved hence another stent was placed over it.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was not requested as the lot number reported was unknown.Investigation summary: one (b)(6) catheter has been returned for evaluation.Balloon had a circumferential rupture exposing the inner guide wire lumen.The distal end of the balloon was noted to be detached and not returned.Both the marker bands are present.No other specific anomalies were noted on the returned device.All the anomalies were observed under microscopic observation.No functional testing was performed due to condition of the device.Therefore, the investigation for the reported balloon rupture was confirmed as the balloon had a circumferential rupture exposing the inner guide wire lumen.The investigation was also confirmed for the balloon detachment as the distal end of the balloon and catheter was noted to be detached and not returned for evaluation.A definitive root cause for the reported balloon rupture and balloon detachment 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.

• Brand Name: VACCESS PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens 75751
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13540528
• Report Number: 2020394-2022-00105
• Device Sequence Number: 14382684
• Product Code: LIT
• UDI-Device Identifier: 00801741121357
• UDI-Public: (01)00801741121357
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K111850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2022

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: VA8094
• Device Catalogue Number: VA8094
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 02/16/2022
• 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 Sex: Unknown