MAUDE Adverse Event Report: CORDIS CORPORATION ELITECROSS; CATHETER FOR CROSSING TOTAL OCCLUSIONS

Catalog Number	MGC39140X
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during deep vein last week, while using one of the 132cm elitecross extra support catheter, the white end piece ending up breaking off after one use.The device will be returned for evaluation.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, during deep vein last week, while using one of the 132cm elitecross extra support catheter, the white end piece ending up breaking off after one use.The device will be returned for evaluation.The user was trained in using the device.The device was stored and opened in a sterile field.The device was used in the patient.Additional information was requested; however, was not obtained after multiple attempts made.The reported ¿brite tip/distal tip separated¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Factors such as vessel anatomy, user handling, and concomitant devices could be a contributing factor.All catheters require manipulation/torqueing, which is a dynamic process once it enters the patient due to external factors such as temperature, time of exposure in body, individual patient anatomical structures, storage conditions, and operator technique in torquing and manipulating the catheter.If a catheter does not move as expected, the operator is trained to stop and investigate the cause before continuing to avoid further damage to the catheter, such as a separation.The information available does not suggest a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.
Event or Problem Description
As reported, during deep vein last week, while using one of the 132cm elitecross extra support catheter, the white end piece ending up breaking off after one use.The device will be returned for evaluation.The user was trained in using the device.The device was stored and opened in a sterile field.The device was used in the patient.Additional information and device return was requested; however, neither were not obtained after multiple attempts made.

• Brand Name: ELITECROSS
• Common Device Name: CATHETER FOR CROSSING TOTAL OCCLUSIONS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 2301 centennial blvd; jeffersonville, indiana 47130 ; 7863138372
• MDR Report Key: 20797316
• Report Number: 1016427-2024-00041
• Device Sequence Number: 12444141
• Product Code: PDU
• UDI-Device Identifier: 20705032067536
• UDI-Public: (01)20705032067536(17)251011(10)H0000342
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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
• Device Expiration Date: 10/11/2025
• Device Catalogue Number: MGC39140X
• Device Lot Number: H0000342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2023
• 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: UNKNOWN.
• Patient Sex: Unknown