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

Model Number	CQF75108
Medical Device Problem Codes	Inflation Problem (1310); 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: 10/2022).
Event or Problem Description
It was reported 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.
Event or Problem Description
It was reported during a treatment of a stenosis in the superior vena cava just beyond the cephalic arch, the balloon allegedly ruptured.It was further reported that the balloon allegedly deformed and had an inflation issue.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.Therefore, a device history record review is not required.Investigation summary: the sample was not returned for evaluation, however, an electronic x-ray image was submitted and reviewed.The x-ray shows the angioplasty balloon inflated near the cephalic arch and centrally within the superior vena cava and is noted not to be properly inflated.However, no conclusions can be made regarding the alleged balloon rupture from the image submitted.Further reports containing venograms and operative report review are needed for a more inclusive finding.Based on the medical review, the reported inflation issue can be confirmed for however no other findings were determined based on the x-ray review.The investigation is inconclusive for the reported balloon rupture and material deformation, as the device was not returned for evaluation.The investigation is confirmed for the reported inflation issue, as the device was not be fully inflated in the x-ray image submitted.The definitive root cause for the reported balloon rupture, inflation issue and material deformation could not be determined based upon available 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: 10/2022), g3, h6(device, method).H11: h6(result and 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 : device not returned.

• 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: 12142599
• Report Number: 2020394-2021-01299
• Device Sequence Number: 4199619
• 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): 08/19/2021

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: REDY1984
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 09/29/2021
• 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