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

Catalog Number	CQ5054
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ultrasound guided angioplasty procedure in the proximal anastomotic stenosis via the left forearm of radial artery, the pta balloon allegedly ruptured at 25 atm.It was further reported that the pta balloon was removed from the sheath.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 01/2024).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 during an ultrasound guided angioplasty procedure in the proximal anastomotic stenosis via the left forearm of radial artery, the pta balloon allegedly ruptured at 25 atm.It was further reported that the pta balloon was removed from the sheath.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.One photo was received and reviewed.The photo shows the conquest balloon with blood residue.The outer packaging can also be seen.The label information matches with the information available in trackwise.The expiration date seen on the label is prior to the event occurrence date.Therefore, the investigation is inconclusive for the reported catheter burst as no objective evidence was provided for review.However, investigation is confirmed for the reported use of the expired product as the user reported the date of use was after the date of expiration.Per the product instructions for use, devices are to be used by the "use by" date.The user used an expired product.Therefore, the definitive root cause was determined to be use-related.However, a definitive root cause for the reported catheter shaft burst could not be determined based upon the provided information.Labeling review: the current ifu (instructions for use) states "rotate inventory so that the catheters and other dated products are used prior to the ¿use-by date¿." per the reported event details, the user attempted to use the device even after it was expired.This is outside of the indications for use per conquest ifu (baw5220201, rev.6).H10: g3, h6 (method).H11: d4 (unique identifier (udi) #), h6 (device, result, conclusion).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.

• 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: 20206308
• Report Number: 2020394-2024-01409
• Device Sequence Number: 7643233
• Product Code: DQY
• UDI-Device Identifier: 00801741062803
• UDI-Public: (01)00801741062803(11)210317(17)240131(10)REFP2253
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: 01/31/2024
• Device Catalogue Number: CQ5054
• Device Lot Number: REFP2253
• 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: 08/19/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 01/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2021
• 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