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

Catalog Number	CQ7586
Medical Device Problem Codes	Deflation Problem (1149); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
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 is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiry date: 06/2026).H11: section a through f - the information provided by bd represents all of 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, the pta balloon allegedly had deflation problem.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly had deflation problem.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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 pta dilatation catheter was received for evaluation.During visual evaluation, the balloon appeared to be prolapsed at the distal end.No hole/puncture was noted to the balloon.During functional testing, an in-house presto inflation device was used to inflate the balloon.The balloon did not inflate so, an attempt to insert an in-house guidewire to the inflation lumen via the proximal end was made but it was unsuccessful but heavy resistance was encountered.Under microscopic observation, saline residue was noted to the guidewire.No further testing performed.Therefore, the investigation remains inconclusive for the reported deflation problem as functional test could not be carried out due to presence of saline residue.However, the investigation is confirmed for the identified material deformation as the distal end of the balloon was noted to be prolapsed.A definitive root cause for the reported deflation problem and identified 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.H10: g3, h6 (device, method).H11: d4 (unique identifier (udi) #), h6 (result, conclusion).H11: section a through f: the information provided by bd represents all of 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: 20179021
• Report Number: 2020394-2024-01404
• Device Sequence Number: 8298382
• Product Code: DQY
• UDI-Device Identifier: 00801741063121
• UDI-Public: (01)00801741063121(17)260630(10)REHU2512
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K083657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2025

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: 06/30/2026
• Device Catalogue Number: CQ7586
• Device Lot Number: REHU2512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 01/23/2025
• 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 Age: 65 YR
• Patient Sex: Male