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	09/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18099958 presented no issues during the manufacturing process that can be related to the reported event.Complaint conclusion: as reported, the distal end of a 7f 23cm brite tip straight catheter sheath introducer was attempted to be used but was frayed.The device was replaced with another brite tip csi and the procedure completed.There was no reported patient injury.The device was prepped as per the instructions for use (ifu).The product was not returned for analysis.A product history record (phr) review of lot 18099958 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¿ could not be confirmed.Storage and/or 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, ¿do not use if package is open or damaged.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.
Event or Problem Description
As reported, the distal end of a 7f 23cm brite tip straight catheter sheath introducer was attempted to used but was frayed.The device was replaced with another brite tip csi and the procedure completed.There was no reported patient injury.The device was prepped as per the instructions for use (ifu).The device was discarded and will not be returned for evaluation.

• 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: 15567661
• Report Number: 9616099-2022-06045
• Device Sequence Number: 12252021
• Product Code: DYB
• UDI-Device Identifier: 10705032000314
• UDI-Public: (01)10705032000314(17)250331(10)18099958
• 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): 10/07/2022

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: 03/31/2025
• Device Model Number: 401723M
• Device Catalogue Number: 401723M
• Device Lot Number: 18099958
• 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: 09/12/2022
• Initial Report FDA Received Date: 10/07/2022
• Date Device Manufactured: 04/05/2022
• 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: BRITE TIP CSI
• Patient Sex: Unknown