MAUDE Adverse Event Report: CORDIS CORPORATION SUPER TORQUE; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 532642

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/23/2024

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, there were blue flakes found within the packaging of a 6f multi-purpose (mp) a2 100cm 2 side-hole (sh) super torque angiographic catheter.The user put it to the side to give to supply and proceeded to get another catheter of the same size and curve.He inspected the packaging and noticed no defects.He handled off the catheter to a sterile technician.During the cardiac catheterization procedure under x-ray, the provider felt something on his hands.He looked down at his hands and noticed blue plastic flakes on his sterile gloves.When the lights came on (as they turn off when using x-rays) there was blue plastic flakes on the sterile field.There were no reports of patient injury.The provider changed out his sterile gloves and proceeded to remove the catheter that was in the right heart atrium.He did this as precaution since the blue flakes were the same color of the catheter that was removed.The sterile team inspected the field and removed any particles from the field.The entire item lot was removed from inventory.The devices will not be returned for evaluation.

Manufacturer Narrative

Section g3 was corrected to reflect the aware date of 22-mar-2024.

• Brand Name: SUPER TORQUE
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 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 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 18991946
• MDR Text Key: 339338107
• Report Number: 9616099-2024-00091
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032012164
• UDI-Public: 10705032012164
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K862244
• 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
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532642
• Device Lot Number: 18102461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/14/2022
• 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 Age: 33 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Hispanic
• Patient Race: White