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

Catalog Number	CQF7584
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Open or Remove Packaging Material (2922); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
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 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 during an angioplasty procedure using the conquest 40 pta balloon, the balloon protective plastic tube was allegedly stuck.It was further reported that when it was pulled, the plastic sheath came lose at the clear plastic hub.The procedure was completed using another balloon.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 catheter returned for evaluation.Upon visual inspection, the outer catheter shaft of the gw lumen is detached from the within the hub.It was noted that from the detachment, the inner gw lumen is exposed and appears to be kinked and flattened.The device was also received with a stylet loaded and the balloon protector.No other anomalies noted.No functional testing was performed due to the condition of the device returned.One photo was provided and reviewed.The photo shows the outer shaft of the gw lumen is detached within the hub.Balloon was not seen in the provided photo.No other anomalies were noted.Therefore, the investigation is inconclusive for the reported difficulty in removing packaging material as reported condition of the issue could not be replicated in the laboratory.However, the investigation is confirmed for the reported detachment as outer shaft of the gw lumen is detached within the hub.A definitive root cause for the reported difficulty opening the packaging material and detachment 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 d2b (mcw: lit), 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
It was reported that during an angioplasty procedure using the conquest 40 pta balloon, the balloon protective plastic tube was allegedly stuck.It was further reported that when it was pulled, the plastic sheath came lose at the clear plastic hub.The procedure was completed using another balloon.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: 23400550
• Report Number: 2020394-2025-01789
• Device Sequence Number: 10034202
• Product Code: DQY
• UDI-Device Identifier: 00801741060557
• UDI-Public: (01)00801741060557(17)280430(10)REKS1660
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 12/08/2025

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: CQF7584
• Device Lot Number: REKS1660
• 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: 10/07/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 01/20/2026
• 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