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

Catalog Number CQ5064

Device Problems Difficult to Remove (1528); Material Rupture (1546)

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

Event Date 10/11/2023

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo and video were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 11/2024) h11: section a through f: the information provide 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 not returned.

Event Description

It was reported that during an angioplasty procedure in the brachial artery, the balloon was allegedly ruptured after expansion of 20 atm.It was further reported that a small hole was allegedly found near the tip of the balloon upon removal.The procedure was completed by using another device.There was no reported patient injury.

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: the physical device was not returned for evaluation.One photo was reviewed.The photo shows the catheter package, in which the product details could be verified and the shaft, in which a syringe was connected to the inflation luer.Leaking of water is noted around the balloon and the balloon was noted to be in deflated condition.However, the source of leak couldn¿t be observed.No other anomalies noted.One video reviewed.The video shows water leaking from the balloon material near to its distal end.No other anomalies noted.Although the submitted photo shows the leakage of water around the balloon, and the cause was unidentified.However, the submitted video confirms the source of the leak on the balloon material near to its distal end.Hence, the investigation is confirmed for the reported balloon rupture.However no objective evidence of sheath removal difficulty could be noted in the submitted video and photo, so the investigation remains inconclusive.A definitive root cause for the reported balloon rupture and sheath removal difficulty 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: 11/2024), g3, h6 (device, method).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 in the brachial artery, the pta balloon was allegedly ruptured longitudinally after expansion of 20 atm.It was further reported that a small hole was allegedly found near the tip of the balloon upon removal.Furthermore, there was slight difficulty in retracting the balloon through the introducer sheath.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 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: 18054941
• MDR Text Key: 327144076
• Report Number: 2020394-2023-00977
• 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: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• 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: REFZ0834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/24/2023
• 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