MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. Conquest; PTA Balloon Dilatation Catheter

Catalog Number	CQ7584
Medical Device Problem Codes	Break (1069); Difficult to Open or Remove Packaging Material (2922); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, prior to a percutaneous transluminal angioplasty (pta) procedure using the conquest balloon catheter.Prior to the procedure, the balloon catheter allegedly was broken.There was no patient contact.
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.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
A patient was prepared for a percutaneous transluminal angioplasty (pta) procedure using a conquest balloon catheter.Prior to the procedure, upon removal of the device from its packaging, a split was observed in the catheter, rendering the device unusable.A replacement balloon catheter was used to complete the procedure.There was no patient contact.
Additional Manufacturer Narrative
H11: the initial mdr was inadvertently submitted with a g3 date of 05/04/2026.The correct g3 date is 05/05/2026.Manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: one conquest device was returned for evaluation.The balloon guard was returned loaded over the balloon.A tear was noted to the catheter shaft just proximally to the proximal balloon joint.An attempt was made to remove the balloon guard, and heavy resistance was required to remove.After removal of the balloon guard, the balloon was attempted to be inserted through a go / no go gauge per manufacturing procedure mpa923.However, the insertion attempt was unsuccessful as the balloon did not successfully insert through the gauge.Therefore, the investigation is confirmed for the reported torn catheter.The investigation is also confirmed for the identified balloon guard removal issue.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B3, b5, d4 (unique identifier (udi) #), e1, g3, h6 (device, component, 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: 25270345
• Report Number: 2020394-2026-01333
• Device Sequence Number: 13187641
• Product Code: DQY
• UDI-Device Identifier: 00801741063114
• UDI-Public: (01)00801741063114(11)251021(17)280430(10)REKS3574
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K083657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2026

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: CQ7584
• Device Lot Number: REKS3574
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/27/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 05/25/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2025
• 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