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

Model Number	VDA100202
Medical Device Problem Codes	Retraction Problem (1536); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard 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 bard.
Event or Problem Description
It was reported that during a valvuloplasty procedure in a venous stenosis, the ptv balloon allegedly detached and had retraction issues through the sheath.The balloon and sheath were removed together as one unit.A snare device was used to remove the detached material.No further treatment was needed.There was no reported patient injury.
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.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned for evaluation.A visual inspection found the balloon to be completely detached from the catheter shaft at both balloon weld locations.Additionally the returned balloon segment was inverted and slightly prolapsed at one end.Therefore, the investigation is confirmed for a complete balloon detachment and retraction issues.Resistance during removal of the balloon likely resulted in the identified detachments.However, the definitive root cause for the identified retraction issue or detachment could not be determined based on the available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
Event or Problem Description
It was reported that during a valvuloplasty procedure in a venous stenosis, the ptv balloon allegedly detached and had retraction issues through the sheath.The balloon and sheath were removed together as one unit.A snare device was used to remove the detached material.No further treatment was needed.There was no reported patient injury.

• Brand Name: VIDA BALLOON VALVULOPLASTY CATHETER
• Common Device Name: BALLOON VALVULOPLASTY CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7712777
• Report Number: 2020394-2018-01263
• Device Sequence Number: 13815986
• Product Code: OMZ
• UDI-Device Identifier: 00801741090912
• UDI-Public: (01)00801741090912
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K131002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2019

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 Expiration Date: 05/16/2021
• Device Model Number: VDA100202
• Device Catalogue Number: VDA100202
• Device Lot Number: 93SC0179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 01/04/2019
• 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