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

Catalog Number	CQ5064
Medical Device Problem Codes	Material Frayed (1262); Material Rupture (1546); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2024
Type of Reportable Event	Malfunction
Additional 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.The investigation of the reported event is currently underway.H10: d4 (expiry date: 06/2024).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 : device pending return.
Event or Problem Description
It was reported that during an angioplasty procedure in the right forearm, after the first expansion when the pressure pump was pressurized to 30 atm, the pta balloon contrast allegedly leaked and cannot be expanded normally.It was further reported that the head of the pta balloon was allegedly found to be ruptured after the balloon was removed.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 received for evaluation.During the visual analysis fiber disturbance, fiber unraveled and material frayed was noted to the balloon.On functional testing in-house inflation device used to inflate the balloon while inflation could identified water leak from the distal end of the balloon.Further the fibers were stripped underwent through the microscopic observation could observed longitudinal rupture in the distal end of the balloon.No further testing was performed.Based on the return sample analysis balloon fiber unraveled, and material frayed could be identified , further longitudinal rupture in the distal end of the balloon was identified during functional testing.Therefore the investigation was confirmed for the identified balloon fiber unraveled, fiber disturbance, material frayed issues and reported balloon rupture issue.A definitive root cause for the identified balloon fiber unraveled, material frayed and reported balloon rupture issue 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 in the right forearm, after the first expansion when the pressure pump was pressurized to 30 atm, the pta balloon contrast allegedly leaked and cannot be expanded normally.It was further reported that the head of the pta balloon was allegedly found to be ruptured after the balloon was removed.The procedure was completed 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: 18769133
• Report Number: 2020394-2024-00253
• Device Sequence Number: 14577701
• Product Code: DQY
• UDI-Device Identifier: 00801741062872
• UDI-Public: (01)00801741062872
• 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): 04/29/2024

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 Catalogue Number: CQ5064
• Device Lot Number: REFU4046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 05/08/2024
• 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 Sex: Unknown