MAUDE Adverse Event Report: CORDIS US. CORP AVANTI; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Catalog Number 504605X

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

As reported, three 5f avanti + sheath introducers, in a row, were found to be very brittle and snapped off inside the patient.The hub broke of the dilator of a 5f avanti + sheath introducer.It was then thrown away.A new 5f avanti sheath was used and proceeded with the case, however, when the physician went to remove the dilator from the sheath, the hub broke off.They were able to insert a wire and remove the sheath and dilator entirely.An additional sheath was opened to check integrity and it also snapped at the dilator.There were no reports of patient injury.Three catheters were at the table but only one was inserted in patient.All 5 devices from lot were pulled.This device was used for an ep ablation.The device was flushed prior to use.The vessel dilator was snapped into place at the hub.There were no difficulties encountered while inserting the dilator.However, there was difficulties while removing the dilator.When the hub of the vessel dilator of the sheath broke off in the patient, the physician was able to advance a wire and remove in whole.There were no difficulties encountered while removing devices through the sheath.There was no excess force used with the device.Resistance was not met while inserting the device.The device was stored and prepped in accordance with the instructions for use (ifu).The device that broke in the patient is currently being evaluated by the hospital, however, the other devices will be returned for evaluation.

Manufacturer Narrative

Event date is unknown.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Section d9 was corrected to reflect that no device was received for this complaint.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: AVANTI
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS US. CORP; 14021 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 18959204
• MDR Text Key: 338430232
• Report Number: 9616099-2024-00082
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 10705032009980
• UDI-Public: 10705032009980
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 504605X
• Device Lot Number: 18049515
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/13/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening