MAUDE Adverse Event Report: CORDIS CORPORATION SI BRITE TIP 8F 11CM STR; INTRODUCER, CATHETER

Model Number	401811M
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	09/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17901123 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 8f 11cm brite tip catheter sheath introducer (csi) was attempted to be inserted into blood vessel.However, it was not smooth due to step.Insertion was attempted several times but the distal end got frayed.The brite tip was replaced with another unknown same sized sheath, insertion was done and the procedure was continued.There was no reported patient injury.The device was discarded and will not be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3, h6, and h10.Complaint conclusion: as reported, attempts were made to insert an 8f 11cm brite tip catheter sheath introducer (csi) into a blood vessel.However, it was not smooth "due to step".Insertion was attempted several times, but the distal end got frayed.The brite tip was replaced with another unknown sheath of the same size.Insertion was successful, and the procedure continued.There was no reported patient injury.The product was not returned for analysis.A product history record (phr) review of lot 17901123 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 events ¿catheter sheath introducer (csi)- insertion difficulty¿ and ¿brite tip/distal tip- frayed/split/torn¿ could not be confirmed.Patient specific anatomical features may have contributed to the insertion difficulty and repeated attempts to gain access with the device may have led to the reported frayed condition.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 8F 11CM 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: 15610867
• Report Number: 9616099-2022-06055
• Device Sequence Number: 2761904
• Product Code: DYB
• UDI-Device Identifier: 10705032000376
• UDI-Public: (01)10705032000376(17)220930(10)17901123
• 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): 10/20/2022

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: 09/30/2022
• Device Model Number: 401811M
• Device Catalogue Number: 401811M
• Device Lot Number: 17901123
• 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: 09/20/2022
• Supplement Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 10/20/2022
• Date Device Manufactured: 10/10/2019
• 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 SAME SIZED SHEATH
• Patient Sex: Unknown