MAUDE Adverse Event Report: Bard Peripheral Vascular, Inc. Conquest; PTA Balloon Dilatation Catheter

Catalog Number	CQ75104
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a patient underwent a percutaneous transluminal angioplasty (pta) procedure under digital subtraction angiography (dsa) guidance using a conquest balloon catheter.During the procedure, after the balloon catheter was advanced to the target lesion site, inflation was initiated using a pressure inflation device.However, the inflation device suddenly lost pressure and rapidly deflated.Multiple attempts were made to re-establish pressure; however, the system failed to maintain inflation.Upon evaluation, a cannula-like rupture of the balloon was identified at approximately 10 atm.There was no reported patient injury.
Additional Manufacturer Narrative
H11: h.4.Device manufacture date: unknown.As the lot number for the device was provided, a review of the device history records will be performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.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.

• Brand Name: Conquest
• Common Device Name: PTA Balloon Dilatation Catheter
• Manufacturer (Section D): Bard Peripheral Vascular, Inc.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): Bard Reynosa S.A. de C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50930843
• Report Number: 2020394-2026-02936
• Device Sequence Number: 21209530
• Product Code: DQY
• UDI-Device Identifier: 00801741063220
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K083657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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: CQ75104
• Device Lot Number: REJP0936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Weight: 154 LB