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

Catalog Number	CQ7588
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent an angioplasty procedure using the conquest pta balloon.During the procedure, the balloon allegedly fails to deflate.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 been returned to the manufacturer for evaluation.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) 2025, a patient underwent an angioplasty procedure via left internal jugular using the conquest pta balloon.During the procedure, the balloon allegedly fails to deflate.The procedure was completed using another balloon.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: received one conquest pta catheter.Upon visual inspection, it was noted an unknown brand 7f sheath was loaded over the balloon, leaving the distal portion of the balloon exposed.No anomalies noted.During functional testing the sheath was retracted proximally from the balloon to expose the whole balloon.Upon retracting, there was narrowing noted on the catheter from the distal tip.In addtion, it was noted bubbles were coming from the balloon, however complaint comments confirm the balloon was stuck with needle for deflation issue.Instead, the balloon was cut to expose the proximal balloon joint.Under microscope, it was noted the glue bullet was within the outer catheter.The glue bullet was pulled from within the catheter and seated on the outer catheter once it was pulled.A kink was noted on the inner gw lumen from where the outer catheter use to be before pulling the glue bullet from within.No further functional testing was performed.Therefore, the investigation is confirmed for the reported deflation issue as the glue bullet was pulled from within the catheter and seated on the outer catheter and also the investigation is confirmed for the identified material deformation as a kink was noted on the inner gw lumen.A definitive root cause for the reported deflation problem and identified material deformation 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.B3, b5, g3, h6 (component, 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 23542215
• Report Number: 2020394-2025-01865
• Device Sequence Number: 21276096
• Product Code: DQY
• UDI-Device Identifier: 00801741063138
• UDI-Public: (01)00801741063138(17)280331(10)REKR1285
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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: CQ7588
• Device Lot Number: REKR1285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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