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

Catalog Number	CQ7574
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: 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 pta dilatation catheter returned for evaluation.During visual evaluation, two kinks and stretching were noted to the catheter.Damage was also noted to the distal tip of the balloon, no other anomalies noted to the device.During functional testing, the sample guide-wire lumen was flushed successfully.The patency of the guide-wire lumen was tested using an in-house guidewire and was unable to be fully inserted due to the kink and stretching of the catheter.No other functional testing was performed.Therefore, the investigation is inconclusive for the reported guidewire advancement failure as guidewire testing could not be completely carried out due to kink and stretching of the device.However, the investigation is confirmed for the identified material deformation as kink was noted to the catheter and damage was also noted to the distal tip of the balloon.Also, the investigation is confirmed for the identified stretching as stretching was noted to the catheter.A definitive root cause for the reported guidewire advancement failure, identified material deformation and stretching could not be determined based upon the provided information.It is unknown whether patient and/or procedural issues contributed to the reported event.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required 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
A patient underwent an angioplasty procedure using the conquest and during the procedure it was reported that the guidewire allegedly cannot pass through the hub.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: 22174118
• Report Number: 2020394-2025-00851
• Device Sequence Number: 9382898
• Product Code: DQY
• UDI-Device Identifier: 00801741062995
• UDI-Public: (01)00801741062995(17)270331(10)REJR0606
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K083657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/03/2025

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: CQ7574
• Device Lot Number: REJR0606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 06/10/2025
• 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