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

Catalog Number	CQ7574
Medical Device Problem Codes	Deflation Problem (1149); Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6)2026, a patient underwent an angioplasty procedure in left forearm using the conquest pta balloon.During the procedure, following balloon dilation, the device could not be withdrawn.To facilitate retrieval, the balloon was punctured with a cannula to achieve deflation, after which it was successfully removed from the patient.The procedure was completed using another balloon.There was no reported patient injury.
Event or Problem Description
On (b)(6), 2026, a patient underwent an angioplasty procedure in left forearm using the conquest pta balloon.During the procedure, following balloon dilation, the device could not be withdrawn.To facilitate retrieval, the balloon was punctured with a cannula to achieve deflation, after which it was successfully removed from the patient.The procedure was completed using another balloon.There was no reported patient injury.
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 not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.E1(b)(6).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.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: the device was not returned for evaluation.Two electronic photos were provided and reviewed.The first photo shows the partial view of the hcp holding the catheter loaded on to the sheath.The second photo shows the hcp holding the conquest balloon catheter loaded on to the sheath.The distal part of the catheter was only visible in the provided photo.Blood residues were noted.No other anomalies were noted.The investigation is inconclusive for the reported deflation problem and entrapment issue as no objective evidence was obtained from the provided photo.A definitive root cause for the reported deflation problem and entrapment issue 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.E1 ((b)(6) ), d4 (unique identifier (udi) #), g3, h6 (method, result, conclusion) 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: 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: 50687620
• Report Number: 2020394-2026-02502
• Device Sequence Number: 10424158
• Product Code: DQY
• UDI-Device Identifier: 00801741062995
• 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,Followup
• Report Date (Section B): 09/22/2026

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: CQ7574
• Device Lot Number: REKX2463
• 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: 08/19/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/09/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2025
• 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