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

Catalog Number	CQ7564
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ultrasound guided percutaneous transluminal angioplasty procedure in the upper limb veins of arteriovenous fistula anastomosis, the pta balloon was used with a dilatation pressure of 30 atm, and when it was being maintained, the pressure was allegedly suddenly released, and the pressure could not be given up.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 (expiration date: 04/2026).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: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.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 percutaneous transluminal angioplasty procedure in the upper limb veins of arteriovenous fistula anastomosis, the pta balloon was used with a dilatation pressure of 30 atm, and when it was being maintained, the pressure was allegedly suddenly released, and the pressure could not be given up.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as malfunction.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: one conquest pta dilatation catheter received for evaluation.Blood residue was noted to the device.Fiber disturbance, stretching and slight inversion were noted to the balloon at the distal tip.An in-house presto inflation device was used to inflate the balloon, and water was noted leaking from the balloon.The balloon fibers were stripped and under microscopic examination, a pinhole rupture was noted to the balloon.No other functional testing performed.Therefore, the investigation is confirmed for the reported inflation issue and identified balloon rupture as a pinhole rupture was noted to the balloon which could have been the cause of the inflation issue.The investigation is also confirmed for the identified material deformation as fiber disturbance, stretching and inversion were noted to the balloon at the distal tip.A definitive root cause for the reported inflation issue, identified balloon rupture and material deformation 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.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 percutaneous transluminal angioplasty procedure in the upper limb veins of arteriovenous fistula anastomosis, the pta balloon was used with a dilatation pressure of 30 atm, and when it was being maintained, the pressure was allegedly suddenly released, and the pressure could not be given up.The procedure was completed using another device.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: 19655500
• Report Number: 2020394-2024-00960
• Device Sequence Number: 6549736
• Product Code: DQY
• UDI-Device Identifier: 00801741062902
• UDI-Public: (01)00801741062902(11)230728(17)260430(10)REHS4725
• 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,Followup
• Report Date (Section B): 11/26/2024

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: 04/30/2026
• Device Catalogue Number: CQ7564
• Device Lot Number: REHS4725
• 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: 06/05/2024
• Supplement Date Received by Manufacturer: 10/21/2024; 11/25/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 11/15/2024; 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2023
• 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 Age: 67 YR
• Patient Sex: Male