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

Catalog Number	DR8094
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454); Material Rupture (1546); Unraveled Material (1664); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.D2b (dqy; lit).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
On (b)(6) 2025, a patient underwent a percutaneous transluminal angioplasty (pta) procedure using the dorado balloon catheter.During the procedure, the balloon catheter allegedly torn.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2025, a patient underwent a percutaneous transluminal angioplasty (pta) procedure using the dorado balloon catheter.During the procedure, the balloon catheter allegedly torn and the base catheter covering stripped away from the balloon.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: one dorado pta balloon catheter returned for evaluation.Upon visual inspection, the device was noted to be loaded with an unknown brand gw.A complete circumferential break was noted to the catheter shaft at the proximal glue joint.The inflation lumens were noted to be exposed from the catheter.The balloon was returned attached.Bunching was noted throughout the balloon, and the distal tip of the balloon was noted to be prolapsed.Peeled pebax were noted to the proximal end of the balloon.Fiber disturbance and unraveling were noted to the distal portion of the balloon.Blood residue was observed on the catheter shaft and throughout the balloon.Microscopic analysis was performed on the anomalies noted on the catheter.No functional testing was performed due to the condition of the device returned.Therefore, the investigation is confirmed for the identified break as complete circumferential break was noted to the catheter shaft at the proximal glue joint.However, the investigation is inconclusive for the reported balloon rupture as functional testing could not be performed due to the condition of the device returned.The investigation is unconfirmed for the reported detachment as no detachment was found on the returned device and balloon was returned attached.The investigation is confirmed for the identified peeled pebax and unraveling as peeled pebax were noted to the proximal end of the balloon and unraveling were noted to the distal portion of the balloon.A definitive root cause for the reported balloon rupture, detachment, identified break, peeled pebax and unraveling 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.B5, d2b (dqy; lit), g3, h6 (device, component, result, conclusion) 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.

• Brand Name: DORADO
• 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: 24158751
• Report Number: 2020394-2026-00063
• Device Sequence Number: 21229982
• Product Code: DQY
• UDI-Device Identifier: 00801741059445
• UDI-Public: (01)00801741059445
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K072283
• 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): 02/24/2026

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: DR8094
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 03/03/2026
• 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
• Patient Sex: Unknown