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

Catalog Number	CQ7578
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent an angioplasty procedure using the conquest balloon catheter.During the procedure, the balloon was allegedly unable to deflate.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 will be performed.The device has not been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.Section a through f ¿ the information provided 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: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: three photos were provided and reviewed.The first and second photos are similar and shows the labelling details in this image which match the information with trackwise and in that a partially inflated balloon with hubs present.The blood residues are visible throughout the balloon.The third image shows the conquest balloon inside a cover; the balloon is also partially inflated.No other anomalies noted.Received one conquest pta dilatation catheter.Upon visual inspection, it was noted the balloon was partially inflated.No anomalies noted to the bifurcate or luers.During functional testing using an in-house presto inflation device, the balloon was subjected to negative pressure but was not succesful in deflating the balloon.An attempt was made to inflate the balloon and was not successful as well.It was noted the glue bullet was seated properly on the catheter as see within the balloon.To confirm this, the balloon was cut and the glue bullet examined.Under microscope examination, the glue bullet was not seated properly and was within the catheter, preventing inflation and deflation.The inner gw lumen was pulled distally, and the glue bullet was pulled from within the catheter and sat correctly on the catheter.No further functional testing was performed.Therefore, the investigation is confirmed for the reported deflation problem as the glue bullet was not seated properly which cause the deflating issue.A definitive root cause for the reported deflation problem 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 g3, h6 (method, result, conclusion) section a through f ¿ the information provided 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 using the conquest balloon catheter.During the procedure, the balloon was allegedly unable to deflate.There was no patient contact.

• 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: 23321576
• Report Number: 2020394-2025-01699
• Device Sequence Number: 10612586
• Product Code: DQY
• UDI-Device Identifier: 00801741063015
• UDI-Public: (01)00801741063015(17)261130(10)REHZ1928
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 12/17/2025

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: CQ7578
• Device Lot Number: REHZ1928
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 12/19/2025
• 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