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

Catalog Number	CQ7574
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2026
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.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) 2026, a patient underwent an angioplasty procedure using the conquest pta balloon.It was reported that during the procedure, the device allegedly kinked.Further it was reported that resistance was felt and upon removal the device fractured.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2026, a patient underwent an angioplasty procedure using a conquest pta dilatation catheter.During the procedure, it was reported that the catheter became kinked.It was further reported that resistance was encountered while withdrawing the device from the treatment site.Upon removal, the balloon catheter was found to be fractured.The procedure was subsequently completed using a new balloon catheter.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: received one conquest pta dilatation catheter in two segments.Upon visual evaluation, one conquest device was received in 2 segments.A complete circumferential break was observed approximately midway through the catheter.No other anomalies were noted.On functional testing, under microscopic visual evaluation, the outer catheter on the proximal segment of the device appeared to be slightly deformed at the location of the break.This deformation appears to align with damage seen with a device kink.No other anomalies were noted at the location of the break under magnification.No functional testing was able to be performed due to the condition of the device.Therefore, the investigation for the reported detachment and removal difficulty as the conquest device was received in two segments, which could have caused difficulty in removing the device.Also, the investigation is confirmed for the material deformation as the outer catheter on the proximal segment of the device appeared to be slightly deformed.A definitive root cause for the reported sheath removal difficulty, deformation, 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.B5, d4 (unique identifier (udi) #), g3, h6 (device, 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 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: 25296430
• Report Number: 2020394-2026-01367
• Device Sequence Number: 13090108
• Product Code: DQY
• UDI-Device Identifier: 00801741062995
• UDI-Public: (01)00801741062995(11)250408(17)271231(10)REKN2243
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 08/11/2026

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: CQ7574
• Device Lot Number: REKN2243
• 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: 05/05/2026
• Supplement Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2025
• 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