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

Catalog Number	CQ5062
Medical Device Problem Codes	Break (1069); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2024
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.However, a photo was provided for review.The investigation of the reported event is currently underway.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 prior to an angioplasty procedure, the pta balloon allegedly broken.The procedure was completed using another balloon.There was no patient contact.
Event or Problem Description
It was reported that prior to an angioplasty procedure, the pta balloon was allegedly broken.The procedure was completed using another device.There was no patient contact.
Additional 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 electronic photo was provided for review.The photo shows a portion of the distal end of a conquest inner packaging sleeve outside of the outer packaging.A tear is noted across the inner packaging sleeve, past the end of the inner packaging tubing.The tear extends from the edge of the sleeve approximately halfway across the sleeve.No damage to the device can be seen in the photo.The device and packaging were also returned for evaluation.The inner packaging was noted to be torn near the distal/bottom edge of the packaging.The device was inside the packaging, and no damage or breaks were noted to the device.The tear of the inner packaging sleeve appears to be originating from the outside edge.The exact cause of the tear cannot be determined.Therefore, the investigation is confirmed for the identified tear in the device packaging, as a tear was noted across the inner packaging sleeve in the returned sample and provided photo.However, the investigation is unconfirmed for the reported break, as no break or damage were noted to the physical device.The definitive root cause for the event could not be determined based upon available information.The cause of the packaging tear cannot be linked to manufacturing or process related issues.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 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.

• 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: 20913153
• Report Number: 2020394-2024-01806
• Device Sequence Number: 20948987
• Product Code: DQY
• UDI-Device Identifier: 00801741062865
• UDI-Public: (01)00801741062865(11)240301(17)261231(10)REJN0090
• 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): 03/25/2025

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: CQ5062
• Device Lot Number: REJN0090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2024
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 03/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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