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

Catalog Number CQ7564

Device Problems Inflation Problem (1310); Leak/Splash (1354); Material Rupture (1546)

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

Event Date 03/16/2024

Event Type  malfunction  

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly cannot be inflated.It was further reported that pta balloon allegedly damaged and leaked.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records will be performed.The device has not been returned to the manufacturer for evaluation.However, a photo and a video were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 01/2026).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.H3 other text : device not returned.

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 reviewed.The photo shows the balloon and a partially visible catheter shaft.An unknown fluid could be observed within the balloon and the balloon was noted to be in deflated condition.No evidence of rupture could be observed.One radiographic video reviewed.It was observed that a balloon within the vessel and in inflated condition, contrast or air was noted to be leaking from the distal aspect of the balloon material.No other anomalies noted.The submitted photo doesn't show any evidence of balloon rupture, the submitted radiographic video confirms leakage from the balloon material.Hence, the investigation was confirmed by the reported balloon rupture.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: b5, d4 (expiry date: 01/2026), g3.H11: h6 (method, 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.

Event Description

It was reported that during an angioplasty procedure in the cephalic vein, the pta balloon allegedly cannot be inflated.It was further reported that pta balloon allegedly damaged and leaked.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: 19085942
• MDR Text Key: 339887369
• Report Number: 2020394-2024-00482
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 05/08/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: CQ7564
• Device Lot Number: REHP2376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/07/2023
• 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
• Patient Age: 65 YR
• Patient Sex: Male