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

Catalog Number	VA8064
Medical Device Problem Codes	Entrapment of Device (1212); 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	01/30/2025
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 will be performed.The device has not been returned to the manufacturer for evaluation.However, images were provided for review.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.
Event or Problem Description
It was reported that during an angioplasty procedure, the tip of the pta balloon was allegedly broken.It was further reported that after several attempts to snare the tip of the fractured pta balloon, a stent was deployed to smash the remains of pta balloon.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: the physical device was not returned for evaluation.One photo was received and reviewed.The photo shows the labelling cover of the vaccess device.The labeling details matches with the details present in trackwise.No other anomalies noted.Three fluoroscopic images were provided and reviewed.The images show the tip of the balloon.The balloon in the forearm with one aspect directed toward the wrist and the second marker of the balloon(tip) directed toward the elbow.There is no wire in the balloon.The second shows a sheath directed toward the wrist and a snare catheter directed toward the tip and the elbow.The snare is near the tip.The third image shows the successful placement of a stent across the tip of the balloon.In this case, the tip of the balloon breaks off from the catheter.The balloon appears to be placed around a curve that may have created a kink in the catheter.Therefore, based on the image review, the investigation is confirmed for both the reported detachment and entrapment issue as balloon breaks off from the catheter and balloon fragment was trapped on the stent.A definitive root cause for the reported detachment and entrapment 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, the tip of the pta balloon was allegedly broken.It was further reported that after several attempts to snare the tip of the fractured pta balloon, a stent was deployed to smash the remains of pta balloon.The current status of the patient is unknown.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.One photo was received and reviewed.The photo shows the labelling cover of the vaccess device.The labeling details matches with the details present in trackwise.No other anomalies noted.Three fluoroscopic images were provided and reviewed.The images show the tip of the balloon.The balloon in the forearm with one aspect directed toward the wrist and the second marker of the balloon(tip) directed toward the elbow.There is no wire in the balloon.The second shows a sheath directed toward the wrist and a snare catheter directed toward the tip and the elbow.The snare is near the tip.The third image shows the successful placement of a stent across the tip of the balloon.In this case, the tip of the balloon breaks off from the catheter.The balloon appears to be placed around a curve that may have created a kink in the catheter.Therefore, based on the image review, the investigation is confirmed for both the reported detachment and entrapment issue as balloon breaks off from the catheter and balloon fragment was trapped on the stent.A definitive root cause for the reported detachment and entrapment 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), g3, h6 (component).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
A patient underwent an angioplasty procedure using vaccess.During the procedure, the tip of the pta balloon was allegedly broken.It was further reported that after several attempts to snare the tip of the fractured pta balloon, a stent was deployed to smash the remains of pta balloon.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: 21475937
• Report Number: 2020394-2025-00222
• Device Sequence Number: 3518603
• Product Code: LIT
• UDI-Device Identifier: 00801741121296
• UDI-Public: (01)00801741121296(17)271105(10)93YJ0045
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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,Followup
• Report Date (Section B): 11/13/2025

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: VA8064
• Device Lot Number: 93YJ0045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 05/07/2025; 11/13/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 05/14/2025; 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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