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

Catalog Number	DR80104
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
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.However, photos were provided for review.The investigation of the reported event is currently underway.D2(lit;dqy).Section a through f ¿ the information provided 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) 2025, a patient underwent an angioplasty procedure through the dorado pta balloon.During the procedure, it was found that the balloon allegedly pulls off the shaft.The procedure was completed by 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: received one dorado pta dilatation catheter.During visual evaluation a complete circumferential break was noted at the proximal balloon joint.The gw and inflation lumen were noted to be exposed from the catheter.The balloon was not returned.Within the break the inner gw lumen was exposed and noted to have a kink.The inflation lumen was noted to have multiple kinks.Two points of narrowing were noted to the catheter shaft; bending was noted to the gw and inflation lumen proximal to the bifurcate.Blood residue was observed on the catheter shaft.During functional testing microscopic analysis was performed on the anomalies noted on the catheter.Functional testing was not performed due to returned condition of detachment.One photo provided and reviewed.The photo shows that the catheter device is visible inside the transparent pouch.The balloon and shaft are detached into 2 segments.The stylet was loaded to the detached balloon.No other anomalies were noted.Therefore, the investigation is confirmed for the reported detachment as the balloon and shaft detached into two segments.A definitive root cause for the reported detachment 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 (lit; dqy).B5, d4 (medical device lot #, unique identifier (udi) #), g3, h6 (patient, component, method, result, conclusion).Section a through f ¿ the information provided 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) 2025, a patient underwent an angioplasty procedure using the dorado pta balloon.Prior to the procedure, the distal end of the balloon allegedly came off completely.The procedure was completed using another balloon.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: 23904105
• Report Number: 2020394-2025-02258
• Device Sequence Number: 7732221
• Product Code: LIT
• UDI-Device Identifier: 00801741059544
• UDI-Public: (01)00801741059544(17)280430(10)93RK0162
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2026

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: DR80104
• Device Lot Number: 93RK0162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 02/19/2026
• 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