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

Catalog Number	DR13582
Medical Device Problem Codes	Break (1069); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent a percutaneous transluminal angioplasty (pta) procedure using the dorado pta balloon catheter.During the procedure, the balloon was allegedly broke or leaking contrast when putting it on catheter.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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.The investigation of the reported event is currently underway.H11: d2b (dqy; lit).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.
Additional Manufacturer Narrative
H11: additional information was received, and the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.B5, d2b (dqy; lit), g3, h6 (patient, device).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 pta balloon catheter.Prior to the procedure, the balloon was allegedly broke or leaking contrast when putting it on catheter.It was further reported that the balloon was noted to have a defect in it even before putting it into the patient or inflating it and it had a hole.The procedure was completed using another device.There was no patient contact.
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: one dorado pta dilatation catheter returned for evaluation.Upon visual inspection, no kinks were noted to the catheter shaft, no anomalies to the luers, bifurcate.A partial circumferential break was noted at the glue joint.No puncture or hole was noted on the device as alleged.During functional testing, an in-house presto inflation device was used to inflate the sample to 8atm, and water was noted to be leaking from the glue joint.Under microscopic observation, a partial circumferential break was noted at the glue joint.No other functional testing performed.Therefore, the investigation is confirmed for the identified break as a partial circumferential break was noted at the glue joint.However, the investigation is unconfirmed for the reported material puncture or hole as no puncture or hole was noted on the device.A definitive root cause for the reported material puncture or hole and identified break could not be determined based upon the provided information.Labelling review :as the reported event did not allege a labeling or use related issue, a labeling review is not required.(dqy; lit), g2, g3, h6 (device, component, method, 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.
Event or Problem Description
On (b)(6) 2025, a patient underwent a percutaneous transluminal angioplasty (pta) procedure using the dorado pta balloon catheter.Prior to the procedure, the balloon was allegedly broke or leaking contrast when putting it on catheter.It was further reported that the balloon was noted to have a defect in it even before putting it into the patient or inflating it and it had a hole.The procedure was completed using another device.There was no patient contact.

• 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: 22164951
• Report Number: 2020394-2025-00844
• Device Sequence Number: 7829181
• Product Code: DQY
• UDI-Device Identifier: 00801741059193
• UDI-Public: (01)00801741059193(17)270709(10)93UJ0025
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 08/04/2025

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: DR13582
• Device Lot Number: 93UJ0025
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 06/19/2025; 08/01/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/14/2025; 08/19/2025
• 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
• Patient Sex: Unknown