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

Model Number	VA8074
Medical Device Problem Codes	Retraction Problem (1536); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 08/2022).
Event or Problem Description
It was reported that during angioplasty procedure the device allegedly ruptured.It was further reported that the balloon had retraction issue.There was no reported patient injury.
Event or Problem Description
It was reported that during angioplasty procedure the device allegedly ruptured.It was further reported that the balloon had retraction issue.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review was performed.This is the first complaint reported to date for this product and lot, therefore a device history record review is not required.Investigation summary: one vaccess pta dilatation catheter has returned for evaluation.On the visual evaluation of the device it appeared bloody the partial catheter returned with the balloon completely detached from the catheter and not returned for evaluation.No other anomalies noted.Microscopic observation was performed to note the detachment of the catheter.No functional performed due to the condition of the device.Therefore, the reported balloon rupture and retraction issue remains inconclusive as the balloon completely detached from the catheter and not returned for evaluation to perform the functional testing.The investigation as confirmed for identified detachment of device as the balloon completely detached circumferential from the catheter on the device which returned for evaluation.A definitive root cause for the alleged balloon rupture and identified detachment of device could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 08/2022).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.

• Brand Name: VACCESS PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11471856
• Report Number: 2020394-2021-00521
• Device Sequence Number: 3430689
• Product Code: LIT
• UDI-Device Identifier: 00801741121319
• UDI-Public: (01)00801741121319
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K111850
• 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): 04/01/2021

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: VA8074
• Device Catalogue Number: VA8074
• Device Lot Number: 93UD0079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 05/13/2021
• 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