MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VIDA PTV DILATATION CATHETER; VALVULOPLASTY CATHETERS

Model Number	VDA100144
Medical Device Problem Codes	Material Rupture (1546); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2021
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 device has not been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.(expiry date: 08/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured at 8 atm.It was further reported that balloon allegedly had tremendous amount of waste in it.The procedure was completed using another device.There was no reported patient injury.
Additional 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 device was returned for evaluation.However, since the complaint sample was used in a hiv patient it was deemed as infectious and no sample evaluation could be performed.Therefore, the investigation is inconclusive for balloon rupture as no functional evaluation could be performed due to the condition of the device.The definitive root cause for the reported balloon rupture could not be determined.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: 08/2023),.
Event or Problem Description
It was reported that during angioplasty procedure, the pta balloon allegedly ruptured at 8 atm.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: VIDA PTV DILATATION CATHETER
• Common Device Name: VALVULOPLASTY CATHETERS
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11743384
• Report Number: 2020394-2021-00933
• Device Sequence Number: 3148922
• Product Code: OMZ
• UDI-Device Identifier: 00801741090837
• UDI-Public: (01)00801741090837
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/28/2021

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: VDA100144
• Device Catalogue Number: VDA100144
• Device Lot Number: 93VE0099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other