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

Catalog Number CQ5064

Device Problems Deflation Problem (1149); Entrapment of Device (1212)

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

Event Date 08/30/2023

Event Type  malfunction  

Event Description

It was reported that during an angioplasty procedure in the arteriovenous fistula, the balloon was allegedly could not be deflated.It was further reported that the balloon allegedly got stuck in the narrowest part of the lesion.Furthermore, the surgeon pierced the balloon with a needle out of the body, which led to leakage of a few contrast agent.The procedure was completed by 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 is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 09/2025).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 pending return.

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.An in-house presto inflation device was used to inflate the balloon.Water was noted leaking from the balloon which was determined to be due to the reported event of the user puncturing the balloon to deflate it.No further functional testing could be performed due to the condition of the returned device.Also, one photo was reviewed.The photo shows the conquest balloon placed in its inner packaging.The outer packaging is seen next to it and the labeling information matches with the information available in trackwise.The conquest balloon appears bloody.No specific anomalies can be noted.Therefore, the investigation is inconclusive for the reported deflation issue as functional testing could not be carried out due to the condition of the device.The investigation is also inconclusive for the reported entrapment of device as the conditions of use could not be replicated in the laboratory.A definitive root cause for the reported deflation problem and entrapment of device 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 (expiration date: 09/2025), g3.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 arteriovenous fistula, the pta balloon allegedly could not be deflated.It was further reported that the balloon allegedly got stuck in the narrowest part of the lesion.Furthermore, the surgeon pierced the balloon with a needle out of the body, which led to leakage of few contrast agent.The procedure was completed by 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: 17816298
• MDR Text Key: 324226414
• Report Number: 2020394-2023-00729
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741062872
• UDI-Public: (01)00801741062872
• 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: 02/02/2024

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: CQ5064
• Device Lot Number: REGX1303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 02/02/2024
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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