MAUDE Adverse Event Report: CORDIS CORPORATION BRITE TIP; INTRODUCER, CATHETER

Catalog Number	401611M
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the 6f 11cm brite tip catheter sheath introducer (csi) could not be inserted to the femoral artery.The doctor tried inserting it in and out several times, but the tip got frayed.So, it was removed.Therefore, it was replaced with a new device.The procedure was completed without any trouble at the puncture site.The device will be returned for evaluation.Additional information was requested; however, the information could not be obtained.
Additional Manufacturer Narrative
As reported, the 6f 11cm brite tip catheter sheath introducer (csi) could not be inserted to the femoral artery.The doctor tried inserting it in and out several times, but the tip got frayed.So, it was removed.Therefore, it was replaced with a new device.The procedure was completed without any trouble at the puncture site.Additional information was requested; however, the information could not be obtained.Based on the limited information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event.Without the return of the device for analysis, the reported customer complaint " catheter sheath introducer (csi) insertion difficulty and brite tip/distal tip frayed/split/torn" could not be confirmed.As per the instructions for use (ifu), which is not intended as a mitigation, if increased resistance is felt upon insertion of the sheath introducer, the cause should be investigated before continuing.If the cause of the resistance cannot be determined, the procedure should be discontinued.Multiple attempts at insertion could have been a contributing factor to the frayed condition reported.The instructions for use (ifu) cautions users to inspect for any signs of damage prior to and during use.The ifu instructs any product with damage to not be used.No preventative or corrective actions will be taken at this time.

• Brand Name: BRITE TIP
• Common Device Name: INTRODUCER, CATHETER
• 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 ; santiago troncoso 808; juarez, chihuahua 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 20195159
• Report Number: 9616099-2024-00302
• Device Sequence Number: 12430958
• Product Code: DYB
• UDI-Device Identifier: 10705032000239
• UDI-Public: (01)10705032000239(17)261130(10)18265875
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K984500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2024

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 Catalogue Number: 401611M
• Device Lot Number: 18265875
• 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
• Initial Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2023
• 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 DEVICE
• Patient Sex: Unknown