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

Model Number CQ7594

Device Problems Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528)

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

Event Date 02/22/2022

Event Type  malfunction  

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly failed to inflate and failed to deflate.It was further reported that the device was able to be pulled back into the sheath and removed the balloon and sheath together.There was no reported patient injury.

Manufacturer Narrative

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.(expiry date: 08/2023).

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly failed to inflate and failed to deflate.It was further reported that the device was able to be pulled back into the sheath and removed the balloon and sheath together.There was no reported patient injury.

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: one conquest pta dilatation catheter was returned for evaluation.No specific anomalies noted during the visual evaluation.In functional testing, an in-house guide wire was able to advance into the flushed inner guide wire lumen.Further, the in-house sheath was flushed and was able to insert into the catheter without any issue.The balloon was inflated with an in-presto device and the balloon inflated to 8 atm and the balloon-maintained shape and pressure.Upon deflation of the balloon, it took approximately 12 seconds for complete deflation, which is within the acceptable limit of product specification.The balloon was able to retract the inserted guide wire and sheath without any issue.Then the balloon was cut, and under microscopic observation, the port holes were noted to be collapsed and the glue bullet was not seated in the correct position.No other functional testing was performed.Therefore the investigation for the reported inflation issue was unconfirmed as the balloon inflated without any issue during the functional testing.The investigation for the reported deflation issue was unconfirmed as the balloon deflated without any issue during the functional testing and took 12 seconds to deflate, which is within the acceptable limit of product specification.The investigation for the reported difficult to remove was unconfirmed as the in-house introducer sheath was able to insert and remove from the catheter without any issue.During the microscopic observation it was noted that port hole collapse, which might lead to the reported inflation and deflation issue.However the definitive root cause for the reported inflation issue , deflation issue and difficult to remove could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 08/2023), g3, h6 (device).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
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13838360
• MDR Text Key: 287525789
• Report Number: 2020394-2022-00190
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741063190
• UDI-Public: (01)00801741063190
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2022

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 Model Number: CQ7594
• Device Catalogue Number: CQ7594
• Device Lot Number: REEW4537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2022
• Initial Date FDA Received: 03/21/2022
• Supplement Dates Manufacturer Received: 05/05/2022
• Supplement Dates FDA Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2020
• 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