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

Catalog Number	CQ7574
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
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 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 bard 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 bard.
Event or Problem Description
On (b)(6) 2025, a patient underwent a percutaneous transluminal angioplasty (pta) procedure using the conquest pta balloon catheter.During the procedure the pressure reached 26 atm and was broken.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: one catheter returned for evaluation.Upon visual inspection, it was noted that there was a burst on the catheter which exposed the inner guidewire lumen.The luers were noted to be bloody and no anomalies were noted to the bifurcate.No further functional testing was performed due to the condition of the device returned.Two photos were provided and reviewed.The first shows the balloon loaded onto guidewire and blood residues seen throughout the balloon.Burst was noted on the catheter shaft.The second photo shows the balloon seen inside the transparent packaging.Burst was noted on the catheter shaft.Blood residues were seen on the balloon.No other anomalies were noted.Therefore, the investigation is confirmed for the reported burst container or vessel as burst was noted on the catheter shaft.A definitive root cause for the reported burst container or vessel could not be determined based upon the provided information.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D4 (unique identifier (udi) #), g3, h6 (method, result, conclusion).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.
Event or Problem Description
On (b)(6) 2025, a patient underwent a percutaneous transluminal angioplasty (pta) procedure using the conquest pta balloon catheter.During the procedure, the pressure reached 26 atm and was broken.There was no reported patient injury.

• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 22730399
• Report Number: 2020394-2025-01192
• Device Sequence Number: 8967933
• Product Code: DQY
• UDI-Device Identifier: 00801741062995
• UDI-Public: (01)00801741062995(11)240819(17)270630(10)REJU0905
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2025

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: REJU0905
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• 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