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

Catalog Number	DR4054
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
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 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 fistulagram angioplasty procedure using the dorado pta balloon catheter.Prior to the procedure when removed the product from the package and pulled the stylet and plastic casing the balloon allegedly felled off from the shaft.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, it was noted the device was returned with the stylet loaded within the lumen.The balloon protector was also loaded over the balloon.There was a complete circumferential break on the proximal balloon joint.It was noted the inflation lumens were exposed and had a circumferential break as well.No detachment was present.No anomalies noted to the bifurcate and luers.Microscopic analysis was performed on the proximal glue joint and inflation lumen breaks.No further functional testing was performed.One photo was provided and reviewed.The photo shows the dorado balloon with balloon protector was seen over the balloon.A catheter stylet was observed to be inserted into the distal end of the balloon.The balloon was separated from the catheter.There was a complete circumferential break on the proximal balloon joint.Hubs were not visible in the provided photo.No other anomalies were noted.Therefore, the investigation is unconfirmed for the reported detachment as no detachment was noted to the returned device.However, the investigation is confirmed for the identified break as break was noted on the proximal joint between balloon and catheter.A definitive root cause for the reported detachment and identified break 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: (dqy; lit), 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 fistulagram angioplasty procedure using the dorado pta balloon catheter.Prior to the procedure, when removed the product from the package and pulled the stylet and plastic casing the balloon allegedly felled off from the shaft.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: 23012955
• Report Number: 2020394-2025-01452
• Device Sequence Number: 9769301
• Product Code: LIT
• UDI-Device Identifier: 00801741058486
• UDI-Public: (01)00801741058486(17)280131(10)93NK0197
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 11/24/2025

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: DR4054
• Device Lot Number: 93NK0197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 11/25/2025
• 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