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

Catalog Number	VA80124
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon was allegedly ruptured after the second inflation up to 8 atm.It was further reported that when removing the pta balloon through the introducer sheath, half of pta balloon was torn at the tip of the sheath in the patient, and they had to remove the sheath with most of the pta balloon except for the tip.Reportedly, larger entry site was created by making an incision and the pta balloon tip was removed using forceps.The current status of the patient is reported to be stable.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.Device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H11: d2b (lit; dqy).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.
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 returned for evaluation.During visual evaluation, segment 1 consisted of the catheter.Circumferential break, a compound rupture was noted to the proximal end of the ballon, marker bands were present.Segment 2 consisted of the distal end of the balloon with slight prolapsing and a compound rupture was also noted.No functional testing was performed due to the nature and condition of the complaint.Therefore, the investigation is confirmed for the reported balloon rupture as a compound rupture was noted to the balloon.Also, the investigation is confirmed for the reported detachment and removal difficulty as the device was received with a complete detachment of the balloon and prolapsing was also noted to the balloon, which would have been caused removal difficulties.A definitive root cause for the reported balloon rupture, detachment 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.H10: g3, h6 (method) h11: d2b (lit; dqy), h6 (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.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon was allegedly ruptured after the second inflation up to 8 atm.It was further reported that when removing the pta balloon through the introducer sheath, half of pta balloon was teared at the tip of the sheath in the patient, and they had to remove the sheath with most of the pta balloon except for the tip.Reportedly, larger entry site was created by making an incision and the pta balloon tip was removed using forceps.The current status of the patient is reported to be stable.

• 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: 21503075
• Report Number: 2020394-2025-00240
• Device Sequence Number: 19933444
• Product Code: LIT
• UDI-Device Identifier: 00801741121265
• UDI-Public: (01)00801741121265(17)271018(10)93XJ0086
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 05/06/2025

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: VA80124
• Device Lot Number: 93XJ0086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 05/08/2025
• 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 Age: 86 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic