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

Catalog Number	CQF7584
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Failure to Advance (2524); Device-Device Incompatibility (2919); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
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 will be performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.H11: section a through f ¿ the information provided 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
It was reported that prior to an angioplasty procedure in the cephalic vein arch stenosis, the pta balloon allegedly had a slight resistance to feeding the guidewire.It was further reported that the pta balloon allegedly ruptured upon opening during balloon dilatation.Furthermore, after the balloon ruptured, it was allegedly difficult to recover the balloon through the introducer sheath and there was friction, violent withdrawal.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: the physical device was not returned for evaluation.The photo shows the balloon portion of the conquest 40 in its inner packaging.It is seen unfolded.The hand-written product number and batch number on the packaging match with the information available.No anomalies noted.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the reported balloon rupture, guidewire advancement difficulty and difficult to remove 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.H10: g3, h6 (method).H11: d2b (dqy;lit), d4 (unique identifier (udi) #), h6 (device, result, conclusion).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
It was reported that prior to an angioplasty procedure in the cephalic vein arch stenosis, the pta balloon allegedly had a slight resistance to feeding the guidewire.It was further reported that the pta balloon allegedly ruptured upon opening during balloon dilatation.Additionally, after the balloon ruptured it was difficult to recover the balloon through the introducer sheath and there is there is friction, violent withdrawal.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 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: 20890171
• Report Number: 2020394-2024-01783
• Device Sequence Number: 18311692
• Product Code: DQY
• UDI-Device Identifier: 00801741060557
• UDI-Public: (01)00801741060557(11)231019(17)260731(10)REHV3870
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K120660
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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 Expiration Date: 07/31/2026
• Device Catalogue Number: CQF7584
• Device Lot Number: REHV3870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 03/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2023
• 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