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

Catalog Number	DR4054
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
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 return of the sample is pending.The investigation of the reported event is currently underway.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
On (b)(6) 2025, a patient underwent an angioplasty procedure using the dorado pta balloon at arteriovenous anastomosis site.It was reported that during the procedure, the balloon allegedly ruptured.It was further reported that the shaft and balloon section got teared apart.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2025, a patient underwent an angioplasty procedure using the dorado pta balloon at arteriovenous anastomosis site.It was reported that during the procedure, the balloon allegedly ruptured.It was further reported that the shaft and balloon section got teared apart.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.Upon visual inspection, it was noted the device was returned in two segments a break was noted on the proximal balloon joint.Device was received with an unknown size and brand sheath and dilator.Segment 1 consists of the catheter shaft which was received with a gw loaded within.The gw was extending out from the gw luer and from the break on the distal end.In addition, the inflation lumens were extending out from the break.Bunching was noted on the catheter shaft approximately from the break.Segment 2 consists of the detached balloon portion.It was noted the gw lumen was protruding out from the proximal end and was noted to have multiple kinks.In addition, the inflation lumens were protruding from the proximal break.The distal tip was noted to be prolapsed.Overall, returned devices had blood residue.Microscopic images were taken of the segments however no functional testing required for detachment.Detached balloon was examined under microscope, and no visible rupture was noted on the balloon.Functional testing was not performed for balloon rupture as the device was received detached.Therefore, the investigation is confirmed for the reported detachment as the device was returned in two segments and also the investigation is inconclusive for the reported balloon rupture as the functional testing was not performed for balloon rupture as the device was received detached.A definitive root cause for the reported balloon rupture and 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 (dqy; lit), g3, h6 (method, result).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.

• 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: 23739786
• Report Number: 2020394-2025-02114
• Device Sequence Number: 8413573
• Product Code: LIT
• UDI-Device Identifier: 00801741058486
• UDI-Public: (01)00801741058486(17)280410(10)93RK0079
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

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: DR4054
• Device Lot Number: 93RK0079
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 02/24/2026
• 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