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

Catalog Number	CQ5084
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
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 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
A patient underwent a percutaneous transluminal angioplasty (pta) procedure using the conquest pta balloon catheter.During the procedure, the balloon allegedly would not deflate.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 partially inflated balloon catheter was loaded within a sheath.The distal tip of the balloon was prolapsed.Minor raised peebax was noted on the balloon and minor fiber disturbance where the fibers were in an uneven pattern were observed near the proximal end of the balloon.The sheath distal tip was noted to be flared.No anomalies noted to the to the luers, bifurcate or glue fillets.During functional testing, an in-house presto inflation device was used to subject the balloon to negative pressure but no water could be aspirated.The balloon was then cut and removed to examine the port hole.Under microscopic examination, it was noted the glue bullet was not seated correctly on the catheter but was within the catheter.There was also a kink on the inner gw lumen.No other functional testing performed.Therefore, the investigation is confirmed for the reported deflation problem as the glue bullet was not seated correctly on the catheter.Also, the investigation is confirmed for the sheath removal difficulty as the sheath loaded on the device was noted to be flared on the distal tip, which could have caused difficulty in removing the device through the sheath.The investigation is confirmed for the identified material deformation as balloon was noted to be prolapsed and minor raised peebax noted on the balloon.Minor fiber disturbance where the fibers were in an uneven pattern were observed near the proximal end of the balloon and kink noted on inner guidewire lumen.A definitive root cause for the reported deflation problem, sheath removal difficulty 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.B5, d4 (unique identifier (udi) #), g3, h6 (device, component, 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 52-year-old male patient underwent a percutaneous transluminal angioplasty (pta) procedure using the conquest pta balloon catheter.During the procedure, the balloon would not deflate.It was further reported that the sheath and balloon were pulled through the venotomy as one unit.Reportedly, manual pressure was held on the venotomy site with no complications.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: 22409542
• Report Number: 2020394-2025-00981
• Device Sequence Number: 8256992
• Product Code: DQY
• UDI-Device Identifier: 00801741063060
• UDI-Public: (01)00801741063060(11)240919(17)270731(10)REJV1486
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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: CQ5084
• Device Lot Number: REJV1486
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2024
• 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 Age: 52 YR
• Patient Sex: Male
• Patient Weight: 59 KG
• Patient Race: Black Or African American