MAUDE Adverse Event Report: CORDIS CORPORATION SI BRITE TIP 6F 11CM STR; INTRODUCER, CATHETER

Model 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	06/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a 6f 11cm brite tip sheath was unable to be inserted smoothly.The user removed the sheath and had noticed that the distal end was frayed.The device was replaced with another unknown sheath and the procedure completed.There was no reported patient injury.The device will not be returned for evaluation because it was discarded.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18042881 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 6f 11cm brite tip sheath was unable to be inserted smoothly.The user removed the sheath and had noticed that the distal end was frayed.The device was replaced with another unknown sheath and the procedure completed.There was no reported patient injury.The femoral artery was the access vessel.The vessel was mildly calcified with mild tortuosity.The intended procedure was an endovascular therapy (evt).There was no scar tissue or tough skin in the area of insertion.The device was opened in a sterile field and stored per instructions for use (ifu).The user was trained to the device.There were no anomalies noted when the device was evaluated prior to opening the package.There was no damage to the packaging.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will not be returned for evaluation because it was discarded.
Additional Manufacturer Narrative
As reported, a 6f 11cm brite tip sheath was unable to be inserted smoothly.The user removed the sheath and had noticed that the distal end was frayed.The device was replaced with another unknown sheath and the procedure was completed.There was no reported patient injury.The femoral artery was the access vessel.The vessel was mildly calcified with mild tortuosity.The intended procedure was an endovascular therapy (evt).There was no scar tissue or tough skin in the area of insertion.The device was opened in a sterile field and stored per the instructions for use (ifu).The user was trained to the device.There were no anomalies noted when the device was evaluated prior to opening the package.There was no damage to the packaging.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device was not returned for analysis as it was discarded.A product history record (phr) review of lot 18042881 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter sheath introducer (csi) insertion difficulty¿ and ¿brite tip/distal tip frayed/split/torn in patient¿ could not be confirmed as the device was not returned for analysis.The exact cause of the issue experienced by the customer could not be determined.Based on the information available for review, access site vessel characteristics (customer reported mild calcification/tortuosity) and handling factors may have contributed to the insertion difficulty and subsequent fraying of the distal tip, especially since the customer reported that there were no anomalies noted prior to patient use.According to the information for safety within the instructions for use (ifu), which is not intended as a mitigation, ¿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.Thread the csi/dilator assembly over the guidewire, grasping the sheath close to the skin to prevent buckling.Using a rotating motion, advance the assembly through the tissue and into the vessel.Detach the vessel dilator from the csi by releasing the snap-fit ring at the hub.Withdraw the guidewire and dilator.To avoid damage to the csi tip, do not withdraw the dilator until the csi is in the vessel.¿ neither the phr review, nor the available information suggest that the reported failures could be related to the design/manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.

• Brand Name: SI BRITE TIP 6F 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: 14806697
• Report Number: 9616099-2022-05753
• Device Sequence Number: 20003009
• Product Code: DYB
• UDI-Device Identifier: 20705032000236
• UDI-Public: (01)20705032000236(17)240731(10)18042881
• 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): 07/13/2022

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: 07/31/2024
• Device Model Number: 401611M
• Device Catalogue Number: 401611M
• Device Lot Number: 18042881
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/06/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 07/13/2022
• Date Device Manufactured: 08/04/2021
• 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 SHEATH
• Patient Sex: Unknown