MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST 40; PTA BALLOON DILATATION CATHETER

Model Number	CQF7564
Medical Device Problem Codes	Material Frayed (1262); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured at 35 atm.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Expiry date: 10/2023.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured at 35 atm.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 40 pta dilatation catheter was received for evaluation.During visual evaluation, the deflated balloon appeared to have residue throughout.The balloon rewrap tool was present.No kinks were noted to the catheter shaft and no anomalies to the luers, bifurcate or glue fillets.Frayed fibers were noted to the balloon.During functional testing, an in-house presto inflation device was used to inflate the balloon.Water was noted leaking from the balloon.The balloon fibers were stripped and under microscopic examination a compound rupture was noted to the balloon.No other functional testing was performed.Therefore, the investigation is confirmed for the reported compound balloon rupture since a compound rupture was noted to the balloon under microscopic examination.The investigation is confirmed for the identified material frayed since frayed fibers were noted to the balloon.A definitive root cause for the reported compound balloon rupture and material frayed 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: d4 (expiry date: 10/2023), g3, h6 (method).H11: h6 (result, conclusion).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.H3 other text : see h10.

• Brand Name: CONQUEST 40
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13173963
• Report Number: 2020394-2021-02151
• Device Sequence Number: 11902726
• Product Code: DQY
• UDI-Device Identifier: 00801741060441
• UDI-Public: (01)00801741060441
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K120660
• 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): 01/11/2022

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: CQF7564
• Device Catalogue Number: CQF7564
• Device Lot Number: REEY3375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 01/18/2022
• 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