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

Catalog Number	DR80104
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Device-Device Incompatibility (2919); Difficult to Open or Remove Packaging Material (2922); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: 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, it was noted there was circumferential break at the proximal balloon joint.In the break, the gw lumen was exposed.Two kinks were noted on the catheter.No anomalies noted to the bifurcate or luers.No functional testing performed due to condition of the device returned.Therefore, the investigation is confirmed for the reported material deformation is confirmed for the reported material deformation as two kinks were noted on the catheter.Also, the investigation is confirmed for the identified break as circumferential break was noted at the proximal balloon joint.The investigation is inconclusive for the reported difficult to remove balloon protector as the conditions of use could not be replicated in the laboratory.The investigation is inconclusive for the reported guidewire advancement failure as no guidewire testing was performed due to circumferential break at proximal balloon joint.A definitive root cause for the reported guidewire insertion issue, material deformation, difficult to remove packaging material 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.D2b (dqy;lit).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 prior to an angioplasty procedure, the dorado pta balloon allegedly bent/broken at the base.It was further reported that it was very difficult to remove the pin and cover.The procedure was completed using another balloon.No patient involvement was reported.

• 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: 23920471
• Report Number: 2020394-2025-02278
• Device Sequence Number: 18476172
• Product Code: LIT
• UDI-Device Identifier: 00801741059544
• UDI-Public: (01)00801741059544(17)280701(10)93TK0157
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 12/09/2025

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: DR80104
• Device Lot Number: 93TK0157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/30/2025
• 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