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

Catalog Number	CQF7574
Medical Device Problem Codes	Material Rupture (1546); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure in the fistula puncture area, when subject to the first pressurization to 30 atm, the pta balloon was inflated and allegedly got fractured.It was further reported that the balloon was deflated and removed directly through 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 return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: 08/2025).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 angioplasty procedure in the fistula puncture area, when subject to the first pressurization to 30 atm, the pta balloon was inflated and allegedly got fractured.It was further reported that the balloon was deflated and removed directly through 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.No photos were provided for review.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 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: d4 (expiry date: 08/2025), g3, h6 (method).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.
Additional Manufacturer Narrative
H10: our firm received an fda email correspondence on 8-july-2024 from mdr data systems team, (b)(4) indicating that the information (specifically the unique device identifier (udi) information in section d) of the previously submitted fda form 3500a, was incorrect and a request was made to submit supplemental report(s) with the entire udi number including the di and pi fields, all numbers, letters, parentheses, and symbols in the ¿unique device identifier (udi) #¿ fields.This supplemental report is in response to that request.H11: d2: medical device type- dqy;lit.D4: medical device expiration date- 08/31/2025.D4: udi- (b)(4).H4: device manufacture date-11/10/2022.
Event or Problem Description
It was reported that during an angioplasty procedure in the fistula puncture area, when subject to the first pressurization to 30 atm, the pta balloon was inflated and allegedly got fractured.It was further reported that the balloon was deflated and removed directly through sheath.The procedure was completed using another device.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: 17951961
• Report Number: 2020394-2023-00880
• Device Sequence Number: 15408909
• Product Code: DQY
• UDI-Device Identifier: 00801741060496
• UDI-Public: (01)00801741060496(11)221110(17)250831(10)REGW2755
• 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,Followup
• Report Date (Section B): 07/16/2024

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: 08/31/2025
• Device Catalogue Number: CQF7574
• Device Lot Number: REGW2755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 12/20/2023; 07/08/2024
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 12/26/2023; 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2022
• 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