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

Catalog Number	V1850150
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
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 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
On (b)(6) 2026, a patient underwent a percutaneous transluminal angioplasty (pta) procedure using the vascutrak balloon catheter.During the procedure, the balloon catheter allegedly ruptured.The procedure was completed using another device.There was no reported patient injury.
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.Two photos were provided and reviewed.Both the photo shows healthcare professional holding the vascutrak device.Rupture was noted near to the proximal end of the balloon.Packaging hoop was seen near to the balloon.No other anomalies were noted.Therefore, the investigation is confirmed for the reported balloon rupture as rupture was noted at the balloon near proximal end.However, the investigation is inconclusive for the reported sheath removal difficulty as no objective evidence was provided for review.A definitive root cause for the reported balloon rupture and 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.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.
Event or Problem Description
On (b)(6) 2026, a patient underwent a percutaneous transluminal angioplasty (pta) procedure using the vascutrak balloon catheter.During the procedure, the balloon catheter allegedly ruptured.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: VASCUTRAK PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 24398223
• Report Number: 2020394-2026-00328
• Device Sequence Number: 9748169
• Product Code: PNO
• UDI-Device Identifier: 00801741061691
• UDI-Public: (01)00801741061691(17)260428(10)GFHP0836
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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 Expiration Date: 04/28/2026
• Device Catalogue Number: V1850150
• Device Lot Number: GFHP0836
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/26/2026
• 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
• Patient Sex: Unknown