MAUDE Adverse Event Report: CORDIS CORPORATION SI BRITE TIP 7F 23CM STR; INTRODUCER, CATHETER

Model Number	401723M
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	12/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, near the opaque marker of 7f 23cm brite tip catheter sheath introducer (csi) was noticed to be frayed.The brite tip csi was attempted to be inserted from the right common femoral artery but was unable to.The 7f brite tip csi was replaced with another 7f 23cm brite tip csi and the procedure completed.There was no reported patient injury.The lesion was the right common iliac artery.The device was discarded and will not be returned for evaluation.
Additional Manufacturer Narrative
The product history review is expected but has not been completed.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, g3, g6, h1, h2, h3, h6, and h10 complaint conclusion: as reported, the area near the opaque marker of a 7f 23cm brite tip catheter sheath introducer (csi) was noted to be frayed.The brite tip csi was attempted to be inserted from the right common femoral artery but was unsuccessful.The 7f brite tip csi was replaced with another 7f 23cm brite tip csi and the procedure was completed.There was no reported patient injury.The lesion was the right common iliac artery.The device was discarded and will not be returned for evaluation.The product was not returned for analysis.A product history record (phr) review of lot 18107431 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device or images for analysis, the reported customer event ¿brite tip/distal tip- frayed/split/torn - in patient¿ could not be confirmed.Procedural/handling factors may have contributed to the reported event.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿if increased resistance is felt upon insertion of the csi, investigate the cause before continuing.If the cause of the resistance cannot be determined and corrected, discontinue the procedure, and withdraw the csi¿ based on the information available and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: SI BRITE TIP 7F 23CM STR
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 16163677
• Report Number: 9616099-2023-06221
• Device Sequence Number: 7052528
• Product Code: DYB
• UDI-Device Identifier: 10705032000314
• UDI-Public: (01)10705032000314(17)250430(10)18107431
• 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,Followup
• Report Date (Section B): 01/23/2023

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: 04/30/2025
• Device Model Number: 401723M
• Device Catalogue Number: 401723M
• Device Lot Number: 18107431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 01/23/2023
• Date Device Manufactured: 05/11/2022
• 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: 7F 23CM BRITE TIP CATHETER SHEATH INTRODUCER (CSI)
• Patient Sex: Unknown