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

Catalog Number	CQ5074
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Rupture (1546); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon catheter tip was allegedly ruptured at 20 atm.It was further reported that the balloon was removed from the sheath.The procedure was completed by 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 returned for evaluation.Unraveled fibers and peeled pebax were noted at the proximal end of the balloon.No specific anomalies were noted on the returned device during the visual evaluation.On functional testing, the balloon was inflated with an in-house presto inflation device.Water was leaking from the balloon; further, the balloon was stripped, and under microscopic observations, a longitudinal rupture was noted in the balloon.No other functional testing was done.One photo was reviewed.The photo was of the balloon catheter coiled within a plastic bag and the balloon appeared in deflated condition.No other specific anomalies and no objective evidence of balloon rupture are noted in the submitted photo.However, during sample analysis of the returned device, unraveled fibers and peeled pebax were noted at the distal end of the balloon during the visual evaluation and during the microscopic observation, a longitudinal balloon rupture was noted.Therefore, the investigation is confirmed for the reported balloon rupture and also confirmed for the identified unraveled fibers and peeled pebax.A definitive root cause for the reported balloon rupture, identified unraveled fibers and peeled pebax 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) 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.H3 other text : see h10.
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 returned for evaluation.Unraveled fibers and peeled pebax were noted at the proximal end of the balloon.No specific anomalies were noted on the returned device during the visual evaluation.On functional testing, the balloon was inflated with an in-house presto inflation device.Water was leaking from the balloon; further, the balloon was stripped, and under microscopic observations, a longitudinal rupture was noted in the balloon.No other functional testing was done.One photo was reviewed.The photo was of the balloon catheter coiled within a plastic bag and the balloon appeared in deflated condition.No other specific anomalies and no objective evidence of balloon rupture are noted in the submitted photo.However, during sample analysis of the returned device, unraveled fibers and peeled pebax were noted at the distal end of the balloon during the visual evaluation and during the microscopic observation, a longitudinal balloon rupture was noted.Therefore, the investigation is confirmed for the reported balloon rupture and also confirmed for the identified unraveled fibers and peeled pebax.A definitive root cause for the reported balloon rupture, identified unraveled fibers and peeled pebax 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.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 or Problem Description
It was reported that during an angioplasty procedure, the pta balloon catheter tip was allegedly ruptured at 20 atm.It was further reported that the balloon was removed from the sheath.The procedure was completed by using another device.There was no reported patient injury.

• 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: 18036950
• Report Number: 2020394-2023-00942
• Device Sequence Number: 12577654
• Product Code: DQY
• UDI-Device Identifier: 00801741062957
• UDI-Public: (01)00801741062957(11)220331(17)250131(10)REGP2203
• 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): 06/22/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Catalogue Number: CQ5074
• Device Lot Number: REGP2203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2022
• 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 Sex: Unknown