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

Model Number	CQ7564
Medical Device Problem Codes	Leak/Splash (1354); Peeled/Delaminated (1454); Material Rupture (1546); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.During visual evaluation, unraveling and fiber disturbance were noted at the distal tip.Peeled pebax was also noted throughout the balloon.No kinks noted to the catheter shaft, no anomalies to the luers, bifurcate, or glue fillets.During functional evaluation, an in-house presto inflation device was used to inflate the balloon and water was noted leaking from below the distal tip.The balloon fibers were stripped and under microscopic examination, a longitudinal rupture was noted to the balloon.No other functional testing performed.One video was provided and reviewed.The video shows a conquest catheter connected to an inflation syringe.Liquid is noted to be leaking from the balloon, but the exact source of the leak cannot be determined.No evidence of balloon rupture and no other specific anomalies noted.Therefore, the investigation is confirmed for the reported uncomplicated longitudinal balloon rupture as a longitudinal rupture was noted to the balloon under microscopic evaluation of the returned sample.The investigation is also confirmed for the identified leak as liquid was seen leaking from the balloon based on the provided video.The investigation is also confirmed for the identified peeled pebax and unraveled fibers as the balloon was noted to have peeled pebax throughout and unraveling near its distal tip.A definitive root cause for the reported uncomplicated longitudinal balloon rupture, identified leak, identified peeled pebax and identified 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.Expiry date: 07/2024.
Event or Problem Description
It was reported that during an angioplasty procedure, through internal arteriovenous fistula of cephalic vein, the pta balloon allegedly ruptured at 28 atm during third inflation.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure through internal arteriovenous fistula of cephalic vein, the pta balloon allegedly ruptured at 28 atm during third inflation.It was further reported that the device and introducer sheath as one unit and the procedure was completed using another device.There was no reported patient injury.
Additional 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.During visual evaluation, unraveling and fiber disturbance were noted at the distal tip.Peeled pebax was also noted throughout the balloon.No kinks noted to the catheter shaft, no anomalies to the luers, bifurcate or glue fillets.During functional evaluation, an in-house presto inflation device was used to inflate the balloon and water was noted leaking from below the distal tip.The balloon fibers were stripped and under microscopic examination, a longitudinal rupture was noted to the balloon.No other functional testing performed.One video was provided and reviewed.The video showed a conquest catheter connected to an inflation syringe.Liquid was noted leaking from the balloon but the exact source of the leak could not be determined.No evidence of balloon rupture and no other specific anomalies were noted.Therefore, the investigation is confirmed for the reported longitudinal balloon rupture as a longitudinal rupture was noted to the balloon under microscopic evaluation of the returned sample, and thus the source of the liquid seen leaking from the balloon from the provided video is determined to be from the longitudinal rupture.The investigation is also confirmed for the identified peeled pebax and unraveled fibers as the balloon was noted to have peeled pebax throughout and unraveling near its distal tip.A definitive root cause for the reported longitudinal balloon rupture, identified peeled pebax and identified 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.H10: b5, d4 (expiry date: 07/2024), 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.

• Brand Name: CONQUEST
• Common Device Name: 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: 15724108
• Report Number: 2020394-2022-00866
• Device Sequence Number: 7251558
• Product Code: DQY
• UDI-Device Identifier: 00801741062902
• UDI-Public: (01)00801741062902
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K083657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2022

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
• Operator of Device: Health Professional
• Device Model Number: CQ7564
• Device Catalogue Number: CQ7564
• Device Lot Number: REFV2921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2022
• Supplement Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 130 KG