MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST 40; PTA BALLOON DILATATION CATHETER

Catalog Number	CQF5074
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
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 been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.D2b (dqy;lit) 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 60-year-old male patient underwent a percutaneous transluminal angioplasty (pta) procedure using the conquest 40 pta balloon catheter for cephalic vein fistula.During the procedure, the balloon catheter allegedly cannot rewire.It was further reported that there was a difficulty in retracting the balloon thru the sheath.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: one conquest 40 pta dilatation catheter returned for evaluation.Upon visual inspection, no kinks were noted to the catheter shaft.No anomalies to the luers, bifurcate or glue fillets.The device was noted to be bloody within the balloon.During functional testing, the device guidewire lumen was flushed.The patency of the guidewire lumen was tested using an in-house guidewire, and it was able to be inserted without issues.An in-house sheath was flushed.Using an in-house presto inflation device, the balloon was subjected to negative pressure and was able to insert through the introducer sheath without issue.Balloon was inflated to nominal pressure and deflated without issue.The balloon catheter was retracted without no issue through the sheath.No other functional testing performed.Therefore, the investigation is unconfirmed for the reported sheath removal issues as the balloon was inserted and retracted without issue through the sheath.Also, the investigation is unconfirmed for the guidewire insertion issues as the guidewire was able to be inserted without issues.A definitive root cause for the reported difficulty removing from sheath and guidewire advancement failure 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.D2.B.(dqy; lit), 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 60-year-old male patient underwent a percutaneous transluminal angioplasty (pta) procedure using the conquest 40 pta balloon catheter for cephalic vein fistula.During the procedure, the balloon catheter allegedly cannot rewire.It was further reported that there was a difficulty in retracting the balloon thru the sheath.There was no reported patient injury.

• Brand Name: CONQUEST 40
• 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: 22402853
• Report Number: 2020394-2025-00973
• Device Sequence Number: 9795404
• Product Code: DQY
• UDI-Device Identifier: 00801741060205
• UDI-Public: (01)00801741060205(17)270930(10)REJX3365
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K120660
• 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): 08/13/2025

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: CQF5074
• Device Lot Number: REJX3365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 07/04/2025
• Supplement Report FDA Received Date: 08/18/2025
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 95 KG