MAUDE Adverse Event Report: CORDIS US CORP. ADROIT; CATHETER, PERCUTANEOUS

Catalog Number 67205200

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/26/2023

Event Type  Injury  

Manufacturer Narrative

The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 6f adroit extra back-up 3 (xb 3) guiding catheter was introduced through the artery there was no resistance; but it was seen that it did not go up; and when it was taken out, the blue cover was undone, and the wire could be seen.When the device was inserted through the artery, more force than usual was needed, and the blue outer material of the catheter fell apart.The artery was then aspirated to remove the remains of the blue plastic.There was no reported patient injury.The device was being used for acute obstruction due to infarction.Lesion calcification and tortuosity are unknown; there was seventy percent (70%) stenosis.The intended procedure was reported to be post infarction treatment.The product was stored, handled, and prepped according to the instructions for use (ifu).Prior to opening the package, the curve did not seem correct to the material description.There was no difficulty experienced in prepping the device.There was no difficulty removing the device from the sterile packaging.The patient was not hospitalized or require extended hospitalization because of this event.The device is expected to be returned for evaluation.Three (3) pictures of the device were provided for review.

Manufacturer Narrative

The device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: ADROIT
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 18412889
• MDR Text Key: 331544166
• Report Number: 9616099-2023-06680
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 67205200
• Device Lot Number: 18012251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/30/2021
• 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
• Treatment: UNKNOWN WIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female