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

Catalog Number CQ7554J

Device Problems Difficult to Remove (1528); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2024

Event Type  malfunction  

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the conquest products that are cleared in the us.The pro code and 510k number for the conquest products is identified in d2 and g4.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: 06/2026).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.H3 other text : device pending return.

Event Description

It was reported that during an angioplasty procedure, after complete expansion, when the pta balloon was tried to be removed, the balloon allegedly didn't move at all.It was further reported that further a stronger force was tried to remove the balloon however, there had a possibility that the guidewire would break.Reportedly the balloon was removed with the guidewire.The procedure was completed using another device.There was no reported patient injury.

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.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the conquest products that are cleared in the us.The pro code and 510k number for the conquest products is identified in d2 and g4.H10: d4 (expiration date: 06/2026), g3, h6 (device).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 Description

It was reported that during an angioplasty procedure, after complete expansion, when the pta balloon was tried to be removed, the balloon allegedly didn't move at all.It was further reported that a stronger force was tried to remove the balloon, however, there had a possibility that the guidewire would break.Reportedly, the balloon was removed with the guidewire.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: CONQUEST
• Type of Device: 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: 18746181
• MDR Text Key: 335848840
• Report Number: 2020394-2024-00239
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741127373
• UDI-Public: (01)00801741127373
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CQ7554J
• Device Lot Number: REHU2509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1