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

Model Number	VA8076
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/20/2020
Type of Reportable Event	Serious Injury
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 been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Device - expiration date: 03/2023.
Event or Problem Description
It was reported that during an angioplasty procedure in the distal outflow vein of the fistula, the pta balloon allegedly ruptured.It was further reported that the balloon became stuck in the sheath upon removal and excessive force was used to remove the balloon causing the balloon to detach from the catheter shaft.Reportedly, the detached segment was removed and the vessel stretched due to excessive force.The physician sutured the vessel and conclude the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review was conducted and it was determined that a device history record review was not required.Investigation summary: the device was returned for evaluation.The sample appeared to be bloody and was returned in a sheath with the distal tip buckled that was noted under magnification.The distal end of the balloon was noted to be prolapsed over the distal tip and bunching was noted to the balloon.The balloon to catheter shaft joint was noted to be broken at the proximal end but was still attached to the device through the inner guidewire lumen.The glue bullet was noted to be pulled from its original position under magnification.No other anomalies were noted to the device.No functional testing could be performed due to the nature of the device.Therefore, the investigation is confirmed for the reported retraction problem, as the device was returned stuck inside the introducer sheath and buckling was noted to the sheath.The investigation is confirmed for the reported balloon shaft bond failure, as the balloon shaft bond was noted to be broken and the balloon was noted to be prolapsed.The investigation is inconclusive for the reported balloon rupture, as the rupture could not be tested for during evaluation.The definitive root cause for the reported balloon rupture, retraction problem and the balloon joint failure could not be determined based upon available 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.
Event or Problem Description
It was reported that during an angioplasty procedure in the distal outflow vein of the fistula, the pta balloon allegedly ruptured.It was further reported that the balloon became stuck in the sheath upon removal and excessive force was used to remove the balloon causing the balloon to detach from the catheter shaft.Reportedly, the detached segment was removed and the vessel stretched due to excessive force.The physician sutured the vessel and conclude the procedure.There was no reported patient injury.

• Brand Name: VACCESS PTA DIALATION CATHETER
• Common Device Name: DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10132230
• Report Number: 2020394-2020-03739
• Device Sequence Number: 11630092
• Product Code: LIT
• UDI-Device Identifier: 00801741121326
• UDI-Public: (01)00801741121326
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VA8076
• Device Catalogue Number: VA8076
• Device Lot Number: 93PE0161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 09/03/2020
• 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: Required Intervention