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

Catalog Number	CQF75108
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
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 40 pta balloon.During the procedure, the balloon allegedly inverted along the proximal segment.It was further reported that it could not be removed from the sheath.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.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.
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 40 pta dilatation catheter.Upon visual inspection, it was noted the device was returned loaded within an unknown brand sheath.The distal end of the balloon was extending out of the sheath distal tip.The returned sheath was bloody, and the tubing had blood within the tubing and cockstop.No anomalies noted to the bifurcate or luers.During functional testing, the returned sheath was retracted proximally from the balloon and flushed.Then using an in-house presto inflation device, the balloon was inflated in order to reshape the prolapse of the balloon.Once deflated, the balloon did not revert back to the prolapse.An attempt was made to remove the returned sheath but was met with high resistance once it reached the distal tip of the balloon.Since removal of the sheath was not possible, it was retracted to the proximal end of the catheter and left there.Balloon was retracted and no further functional testing was performed.Therefore, the investigation is confirmed for the reported sheath removal difficulty as the removal of the sheath was not possible and the investigation is unconfirmed for the material deformation as no deformation was noted on the balloon.A definitive root cause for the reported sheath removal difficulty and 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.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 an angioplasty procedure using the conquest 40 pta balloon.During the procedure, the balloon allegedly inverted along the proximal segment.It was further reported that it could not be removed from 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: 23244009
• Report Number: 2020394-2025-01633
• Device Sequence Number: 16058612
• Product Code: LIT
• UDI-Device Identifier: 00801741060649
• UDI-Public: (01)00801741060649(17)280331(10)REKR2326
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/18/2025

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: CQF75108
• Device Lot Number: REKR2326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 12/22/2025
• 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