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

Model Number CQ5064

Device Problems Deflation Problem (1149); Peeled/Delaminated (1454); Material Rupture (1546); Unraveled Material (1664)

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

Event Date 03/27/2023

Event Type  malfunction  

Manufacturer Narrative

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 video was provided for review.The investigation of the reported event is currently underway.(expiration date: 01/2025) 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.Device not returned.

Event Description

It was reported that during an angioplasty procedure via left forearm, ultrasound revealed that the balloon was allegedly unable to be deflated completely.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure via left forearm, ultrasound revealed that the pta balloon was allegedly unable to be deflated completely.It was further reported that the balloon was found to be burst and was leaking water.Reportedly, the balloon was removed.There was no reported patient injury.

Manufacturer Narrative

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 balloon catheter was returned for evaluation.Peeled pebax, unraveled fiber disturbance, and frayed fibers were noted at the proximal end of the balloon; no other specific anomalies were noted during the visual evaluation.During the functional testing, the balloon was inflated with an in-house presto inflation device, and during the inflation, water was noted to be streaming from the balloon.Further, the balloon was stripped, and under microscopic observation, a longitudinal rupture was noted on the balloon.One video was reviewed.The video balloon had been pressurized with an unknown inflation device, and upon inflating the balloon, water was noted to be streaming out of the balloon.No other specific anomalies are noted.The submitted video shows the leakage on the balloon, and during the sample analysis, it was confirmed that the leakage on the balloon was caused by the longitudinal rupture that was observed under microscopic observation.However, no objective evidence for the deflation issue could be noted during the video review and sample analysis.Peeled pebax, unraveled fiber was also noted on the returned balloon during the visual evaluation.Therefore, the investigation was confirmed for the reported balloon rupture and identified peeled pebax, unraveled fiber and the investigation remains inconclusive for the reported deflation issue.A definitive root cause for the reported balloon rupture, deflation issue and identified peeled pebax and unraveled fibers 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.B5, d4 (expiration date: 01/2025).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.

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 balloon catheter was returned for evaluation.Peeled pebax, unraveled fiber disturbance, and frayed fibers were noted at the proximal end of the balloon; no other specific anomalies were noted during the visual evaluation.During the functional testing, the balloon was inflated with an in-house presto inflation device, and during the inflation, water was noted to be streaming from the balloon.Further, the balloon was stripped, and under microscopic observation, a longitudinal rupture was noted on the balloon.No other functional testing.Also, one video was reviewed.In the video, balloon had been pressurized with an unknown inflation device, and upon inflating the balloon, water was noted to be streaming out of the balloon.No other specific anomalies are noted.The submitted video shows the leakage on the balloon, and during the sample analysis, it was confirmed that the leakage on the balloon was caused by the longitudinal rupture that was observed under microscopic observation.Peeled pebax, and unraveled fiber was also noted on the returned balloon during the visual evaluation.Therefore, the investigation was confirmed for the reported balloon rupture and identified peeled pebax, and unraveled fiber.A definitive root cause for the reported balloon rupture and identified peeled pebax and unraveled fibers 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: 01/2025), 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 via the left forearm, the pta balloon was allegedly found to be burst and was leaking water.It was further reported that an ultrasound revealed that the pta balloon was allegedly unable to be deflated completely.Reportedly, the balloon was removed.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: 17057346
• MDR Text Key: 316587187
• Report Number: 2020394-2023-00391
• 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,Followup
• Report Date: 11/21/2023

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 Model Number: CQ5064
• Device Catalogue Number: CQ5064
• Device Lot Number: REGP3767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 06/05/2023
• Supplement Dates Manufacturer Received: 08/04/2023; 01/08/2024
• Supplement Dates FDA Received: 08/09/2023; 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2022
• 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