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

Model Number VA80104

Device Problems Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2022

Event Type  malfunction  

Event Description

It was reported that during an angioplasty procedure in a upper arm fistula, the tip of the balloon was allegedly broke upon inflation.It was further reported that they were able to retrieve the tip with a snare.There was no reported patient injury.

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 01/2025).

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 vaccess pta dilatation catheter was received in two detached segments.During visual evaluation, segment 1 was noted to consist of the luers/y-body, catheter shaft, inner guide-wire lumen and proximal end of the balloon.The balloon was noted to have a complete circumferential rupture and the inner guide-wire lumen was exposed.The segment was examined under x-ray and the marker bands were present.Segment 2 consisted of the distal end of the balloon and distal tip.Bunching was noted to the balloon.Blood and damage were noted to the distal tip.No functional testing was performed due to the nature of the complaint.Therefore, the investigation is confirmed for the reported detachment as the catheter was received detached in two segments.The investigation is also confirmed for the reported circumferential rupture as the balloon was noted to have a complete circumferential rupture.The investigation is inconclusive for the reported difficult to remove as no evidence of the failure could be determined.A definitive root cause for the reported detachment, circumferential rupture and difficult to remove 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.H10: b5, d4 (expiry date: 01/2025), g3, h6(device).H11: g1, h6(method, result, conclusion).H11:section a through f - the information provided by bd represents all of 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.

Event Description

It was reported that during an angioplasty procedure via left upper arm fistula, the tip of the balloon was allegedly broke upon inflation.It was further reported that the balloon was allegedly burst and had difficulty retracting the device from the patient.Reportedly, they were able to retrieve the tip with a snare.There was no reported patient injury.

• Brand Name: VACCESS
• Type of Device: 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13961871
• MDR Text Key: 288274714
• Report Number: 2020394-2022-00239
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741121258
• UDI-Public: (01)00801741121258
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

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
• Device Operator: Health Professional
• Device Model Number: VA80104
• Device Catalogue Number: VA80104
• Device Lot Number: 93NG0026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 03/31/2022
• Supplement Dates Manufacturer Received: 05/24/2022
• Supplement Dates FDA Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1