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

Model Number	CQ5074
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured.There was no reported patient injury.
Additional 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: the physical device was not returned for evaluation.Two photos were provided and reviewed.The first photo shows the introducer sheath inserted in the patient's body.The conquest balloon seen held close to the sheath.The balloon looks partially deflated and bloody.The second photo shows the introducer sheath inserted in the patient's body.The conquest balloon is seen loaded on a guidewire.The guidewire is inserted in sheath while the balloon is held outside the body.The balloon looks partially deflated and bloody.No specific anomalies noted.One video was provided and reviewed.The video shows the introducer sheath inserted in the patient's body.The conquest balloon is seen loaded on a guidewire.The guidewire is inserted in sheath while the balloon is held outside the body.Liquid is seen streaming from the balloon from an unclear source as the balloon is being inflated.No other anomalies noted.Therefore, the investigation is inconclusive for the reported balloon rupture as no evidence of rupture can be determined.The investigation is confirmed for the identified leak as water is seen streaming from the balloon from the provided video.However, the specific cause of the leak cannot be determined.A definitive root cause for the reported balloon rupture and identified leak could not be determined based upon the provided information.Labelling 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: 05/2024).

• 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: 15184078
• Report Number: 2020394-2022-00647
• Device Sequence Number: 5848105
• Product Code: DQY
• UDI-Device Identifier: 00801741062957
• UDI-Public: (01)00801741062957
• 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
• Report Date (Section B): 07/20/2022

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: CQ5074
• Device Catalogue Number: CQ5074
• Device Lot Number: REFT3285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2021
• 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: 46 YR
• Patient Sex: Male