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

Model Number	VDA100202
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Additional 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: 07/2022).
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon was allegedly would not hold pressure.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon allegedly would not hold pressure.There was no reported patient injury.
Additional 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 vida ptv dilatation catheter has been received for the evaluation.On the visual evaluation, the device was noted bloody and no other specific anomalies were noted.On the functional evaluation, an in-house presto inflation device was used to inflate the balloon to 6 atm.Balloon inflated and maintained pressure and the balloon was then deflated without issue.No other functional testing was performed.Therefore the investigation for the reported inflation issue was unconfirmed, as the balloon was successfully inflated without any issue upon inflation.A definitive root cause for the reported inflation issue 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: d4 (expiry date: 07/2022), g3.H11: e1, g2, 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.

• 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
• 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: 12612003
• Report Number: 2020394-2021-01860
• Device Sequence Number: 1428732
• Product Code: OMZ
• UDI-Device Identifier: 00801741090912
• UDI-Public: (01)00801741090912
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K131002
• 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,Followup
• Report Date (Section B): 11/23/2021

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: VDA100202
• Device Catalogue Number: VDA100202
• Device Lot Number: 93UD0063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 11/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2019
• 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