MAUDE Adverse Event Report: CORDIS CORPORATION DGW .035 FC J3MM 150CM TEF; WIRE, GUIDE, CATHETER

Model Number	502521
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.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.
Event or Problem Description
As reported, the tip of the.035 fc j3mm 150cm tef diagnostic guidewire was deformed out of the box and before the package was open.The box was stored per the instructions for use (ifu) and opened under sterile procedure.A blurred image of a j tip wire was received for evaluation.It appears as if the coating on the distal portion of the wire has fractured and remains on the core wire.There was no reported patient injury.There was no damage noted to the packaging of the device.The procedure completed by opening a second wire from the same box.The product is expected to be returned for evaluation.
Additional Manufacturer Narrative
This is a correction to change the reportability of this complaint to a non reportable status.Additional information was received and an unraveled/stretched condition on the distal tip was observed on the returned guidewire.No anomalies were detecting related to the coating.The malfunction code is changing from coating delaminated-during prep to distal tip-unraveled stretched during prep.
Additional Manufacturer Narrative
This report was generated an error and due to the system limitation, a reported needed to be submitted in order to close this report.

• Brand Name: DGW .035 FC J3MM 150CM TEF
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13549630
• Report Number: 1016427-2022-05390
• Device Sequence Number: 5187051
• Product Code: DQX
• UDI-Device Identifier: 10705032055116
• UDI-Public: (01)10705032055116(17)240831(10)35263581
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K864058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2022

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 Expiration Date: 08/31/2024
• Device Model Number: 502521
• Device Catalogue Number: 502521
• Device Lot Number: 35263581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 02/23/2022; 02/23/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 03/18/2022; 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Patient Sex: Male