MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VIDA; BALLOON VALVULOPLASTY CATHETER

Catalog Number VDA100126

Device Problems Material Rupture (1546); Material Deformation (2976)

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

Event Date 12/21/2023

Event Type  malfunction  

Manufacturer Narrative

H10: 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.However, photos and images were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 01/2025).H11: section a through f ¿ the information provided by bd represents all 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.

Event Description

It was reported that during a valvuloplasty procedure, the pta balloon allegedly popped.It was further reported that the pta balloon was removed and the procedure was completed using another balloon.There was no reported patient injury.

Event Description

It was reported that during a valvuloplasty procedure, the balloon was allegedly ruptured.It was further reported that the balloon was removed, and the procedure was completed using another balloon.There was no reported patient injury.

Manufacturer Narrative

H10: 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 vida balloon catheter was returned for evaluation.Fiber disturbance was observed on the balloon catheter.No other anomalies were noted during the visual evaluation.On the functional testing, the balloon was inflated with an in-house presto inflation device and water was leaking from the balloon near to the distal tip.Further, under microscopic observations, a pin-hole balloon ruptured.No other functional testing.Three radiographic image was reviewed.The initial photo shows a balloon that has been removed and is deflated.No visible defect is noted.The second image shows an occluded iliac vein.The third image is a subtracted image of the stented iliac veins and the final image shows the stents in plane film.No other anomalies.As no objective evidence for reported anomalies noted during the image review, however on the visual observations on returned catheter, fiber disturbance was observed and microscopic observations confirm the evidence of a pin-hole balloon rupture.Therefore, the investigation is confirmed for the reported balloon rupture and identified fiber disturbance.A definitive root cause for the reported balloon rupture and identified fiber disturbance could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiry date: 01/2025).H11: section a through f ¿ the information provided by bd represents all 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.

• Brand Name: VIDA
• Type of Device: BALLOON VALVULOPLASTY 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: 18516147
• MDR Text Key: 333498888
• Report Number: 2020394-2023-01393
• Device Sequence Number: 1
• Product Code: OMZ
• UDI-Device Identifier: 00801741090813
• UDI-Public: (01)00801741090813
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131002
• 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: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VDA100126
• Device Lot Number: 93NG0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 64 YR