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

Catalog Number	VA8084
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: 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.H10: d4 (expiration date: 11/2026).H11: section a through f ¿ the information provide by bd represents all 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 : device pending return.
Event or Problem Description
It was reported that during an angioplasty procedure for a stenosis in the graft, the pta balloon allegedly ruptured, and the partially deflated balloon was allegedly lodged at the sheath.It was further reported that the balloon was allegedly difficult to be removed through the sheath.Furthermore, when tried to remove the balloon through the sheath, the distal two centimeter of the balloon with the shaft were allegedly detached.Reportedly, the missing pieces of the balloon were allegedly located at the distal end of the stent and a stent was placed with the aim of covering the fragments and trapping them in place between the wall of the vessel and the wall of the stent.The procedure was completed using another device.The current status of the patient is unknown.
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 vaccess pta dilatation catheter was received for evaluation.Complete circumferential detachment was observed to the proximal end of the catheter.The proximal catheter segment consisting of the luers was not returned.Another complete circumferential detachment was noted to the proximal end of the device.The balloon had a complete circumferential rupture and the shaft had a complete circumferential detachment.The distal segment consisting of the rest of the balloon and shaft was not returned.Due to the nature of the complaint, functional testing was not performed.Therefore, the investigation is confirmed for the reported entrapment of device and removal difficulty as the device was received with a complete circumferential balloon rupture and complete detachment of the shaft, with the distal portion of the balloon and shaft not returned, which would have been caused due to entrapment and removal difficulties.Thus the investigation is also confirmed for the reported balloon rupture and detachment.A definitive root cause for the reported balloon rupture, detachment, entrapment of device and removal difficulty could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f ¿ the information provide by bd represents all 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.
Event or Problem Description
It was reported that during an angioplasty procedure for a stenosis in the graft, the pta balloon allegedly ruptured, and the partially deflated balloon was allegedly lodged at the sheath.It was further reported that the balloon was allegedly difficult to be removed through the sheath.Furthermore, when tried to remove the balloon through the sheath, the distal two centimeter of the balloon with the shaft were allegedly detached.Reportedly, the missing pieces of the balloon were allegedly located at the distal end of the stent and a stent was placed with the aim of covering the fragments and trapping them in place between the wall of the vessel and the wall of the stent.The procedure was completed using another device.The current status of the patient is unknown.

• Brand Name: VACCESS
• Common Device Name: PTA BALLOON DILATATION 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18824906
• Report Number: 2020394-2024-00297
• Device Sequence Number: 19575871
• Product Code: LIT
• UDI-Device Identifier: 00801741121333
• UDI-Public: (01)00801741121333
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K111850
• 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): 05/07/2024

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 Catalogue Number: VA8084
• Device Lot Number: 93YH0031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown