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

Catalog Number CQ7564J

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

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

Event Date 09/25/2023

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 pta dilatation catheter products that are cleared in the us.The pro code and 510 k number for the conquest pta dilatation catheter products are identified in d2 and g4.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 was returned for evaluation.No specific anomalies were noted on the returned device during the visual evaluation.On functional testing, the balloon was inflated with an in-house presto inflation device and water was leaking from the balloon; further, the balloon fibers were stripped, and under microscopic observations, a pinhole rupture was noted in the balloon.No other functional testing was performed.During the functional testing upon inflation, the balloon leaks and on further analysis of microscopic observation, the source of the leak was noted to be a pinhole balloon rupture.Therefore, the investigation was confirmed for the reported leak and identified balloon rupture.A definitive root cause for the reported leak and identified pin-hole 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 (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.

Event Description

It was reported that during an angioplasty procedure, the pta balloon was allegedly unable to keep the pressure upon inflating and the leakage of contrast medium was allegedly found.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 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: 18407852
• MDR Text Key: 331493057
• Report Number: 2020394-2023-01328
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741127403
• UDI-Public: (01)00801741127403
• 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
• Report Date: 12/22/2023

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: CQ7564J
• Device Lot Number: REHS4712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2023
• 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