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

Model Number	CQF75108
Medical Device Problem Codes	Material Rupture (1546); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
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 not been returned to the manufacturer for evaluation.However, an image was provided for review.The investigation of the reported event is currently underway.(expiry date: 01/2024).
Event or Problem Description
It was reported that during a treatment of stenosis in the superior vena cava just beyond the cephalic arch, the balloon allegedly ruptured at 20 atm.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: the physical device was not returned for evaluation.One medical image was reviewed.The balloon does not appear appropriately inflated at the curvature of its trajectory, no other specific anomalies were noted.From the images provided, no conclusions can be made on the etiology of this event.Based on the image review, the reported balloon rupture was inconclusive as there is no evidence was noted for the balloon rupture and the reported material deformation was confirmed as the balloon not inflated properly at the curvature of its trajectory.Therefore the investigation for the reported balloon rupture was inconclusive as there is no evidence was noted for the balloon rupture in the image review.The investigation for the reported material deformation was confirmed from the image review, as the balloon not inflated properly at the curvature of its trajectory.A definitive root cause for the reported balloon rupture and the material deformation 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: b5, d4 (expiry date: 01/2024),.
Event or Problem Description
It was reported that during a treatment of stenosis in the superior vena cava just beyond the cephalic arch, the balloon allegedly ruptured.It was further reported that the balloon allegedly deformed.There was no reported patient injury.

• 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
• MDR Report Key: 12142595
• Report Number: 2020394-2021-01300
• Device Sequence Number: 14503078
• Product Code: DQY
• UDI-Device Identifier: 00801741060649
• UDI-Public: (01)00801741060649
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K120660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

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: CQF75108
• Device Catalogue Number: CQF75108
• Device Lot Number: REFP4492
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Weight: 91