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

Catalog Number	VA80104
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent a percutaneous transluminal angioplasty (pta) procedure using the vaccess pta balloon catheter.During the procedure the balloon was allegedly got stuck in the sheath.There was no reported patient injury.
Additional Manufacturer Narrative
H11: 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.However, photos were provided for review.The investigation of the reported event is currently underway.Section a through f: the information provided 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
On (b)(6) 2025, a patient underwent a percutaneous transluminal angioplasty (pta) procedure using the vaccess pta balloon catheter.During the procedure the balloon was allegedly got stuck in the sheath.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: received one vaccess pta dilatation catheter.Upon visual inspection, it was noted the pta device was received loaded within an unknown sheath.Overall, the balloon was bloody and received uninflated.No anomalies noted to the y-body.During functional testing the sheath was retracted proximal of the balloon catheter and blood clot, and residue were noted on the catheter.It was flushed by an in-house syringe and bloody water was expelled from the sheath.Then an attempt was made to pull the pta device proximally from the sheath but was not possible due to the bunching at the distal end.Using an in-house presto inflation device the balloon was inflated to np.Upon inflation, the bunching was not present but a bend near the distal end was noted.The balloon was then deflated and took a flat shape.A second attempt was made to pull the pta catheter proximally, but this time would not pass the proximal end of the balloon.The returned sheath could not be removed and further functional testing was not performed.Two photos were provided and reviewed.The first photo shows the health care professional holding the vaccess balloon.Prolapsing was noted at the distal tip of the balloon.Blood residues were seen throughout the balloon.The second photo shows the vaccess device loaded on to the unknown sheath.The distal part of the balloon was seen protruding at distal end of the sheath.Prolapsing was noted at the distal tip of the balloon.Blood residues were seen throughout the balloon.No other anomalies were noted.Therefore, the investigation is confirmed for the reported sheath removal difficulty as the removal of sheath was not possible due to the bunching at the distal end.A definitive root cause for the reported sheath 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 d2b (lit;dqy), d4 (unique identifier (udi) #), g3, h6 (method, result, conclusion).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.

• 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: 23242439
• Report Number: 2020394-2025-01629
• Device Sequence Number: 10419320
• Product Code: LIT
• UDI-Device Identifier: 00801741121258
• UDI-Public: (01)00801741121258(11)250429(17)280416(10)93RK0101
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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 Catalogue Number: VA80104
• Device Lot Number: 93RK0101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2025
• 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
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 63 KG
• Patient Race: Black Or African American