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

Catalog Number	CQ7584
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: 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.H11: 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 a percutaneous transluminal angioplasty (pta) procedure using the conquest pta balloon catheter.During the procedure, the balloon allegedly would not deflate.It was further reported that the balloon got stuck inflated over a super stiff amplatz thru a sheath.Reportedly, the balloon was poked thru a needle to deflate and take it out.The procedure was completed using another device.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 conquest pta dilatation catheter returned for evaluation.Upon visual inspection, it was noted the balloon was bloody with the distal tip prolapsed.No anomalies to the luers, bifurcate or glue fillets.During functional testing, an in-house presto inflation device was used to inflate the balloon but was unable to be inflated.The balloon fibers were then stripped in order to see the port holes.A second attempt was made to inflate the balloon but was not successful.In order to see if there was a blockage within the inflation lumen, a touhy-borst adapter was used to inflate the balloon and did not inflate.The balloon was then cut longitudinal to remove it.It was then noted the glue bullet was not seated correctly on the catheter.No further testing was performed.Therefore, the investigation is confirmed for the reported deflation problem as glue bullet was not seated correctly on the catheter and inflation of the balloon is unsuccessful, it indicates a possible blockage in the inflation lumen which could have caused deflation issues.Also, the investigation is confirmed for the reported sheath removal difficulties as the distal tip of the balloon was prolapsed, which could have been caused due to difficulty in removing from the sheath.A definitive root cause for the reported deflation problem and sheath removal difficulties 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.D4 (unique identifier (udi) #), g2, g3, h6 (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.
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 balloon allegedly would not deflate.It was further reported that the balloon got stuck inflated over a super stiff amplatz thru a sheath.Reportedly, the balloon was poked thru a needle to deflate and take it out.The procedure was completed using another device.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: 22209715
• Report Number: 2020394-2025-00874
• Device Sequence Number: 20982983
• Product Code: DQY
• UDI-Device Identifier: 00801741063114
• UDI-Public: (01)00801741063114(11)250208(17)271130(10)REJZ0698
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

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: CQ7584
• Device Lot Number: REJZ0698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2025
• 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