MAUDE Adverse Event Report: CORDIS CORPORATION SI BRITE TIP 8F 35CM STR; INTRODUCER, CATHETER

Model Number	401835M
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, after removing the a 8f 35cm str si brite tip sheath and the distal end was checked a frayed damage was confirmed at the tip part.The damage was noticed in the patient.There was no reported patient injury.The sheath was used to remove the optease filter and was unsuccessful.Therefore, it was replaced with a new recommended unknown system and the filter was removed.¿regarding the removal method this was not the recommended, but the doctor did it even though he knew the risk of trouble.¿ the product was stored and prepped as per the instructions for use in the lab.No anomalies were noted when the device was taken out of the package.There was no difficulty experienced in prepping the device.The access site was the femoral arteries.The intended procedure/target lesion was the inferior vena cava for filter removal.There was no difficulty tracking through the vasculature and no unusual force was used at any time during the procedure.The device was removed intact from the patient.The device will not be returned for evaluation as the device was discarded at the hospital.
Additional Manufacturer Narrative
As reported, after removing the a 8f 35cm str si brite tip sheath, a frayed condition was confirmed at the tip.The damage was noticed in the patient.There was no reported patient injury.The sheath was used to remove the optease filter and was unsuccessful.Therefore, it was replaced with a new recommended unknown system and the filter was removed.¿regarding the removal method this was not the recommended, but the doctor did it even though he knew the risk of trouble.¿ the product was stored and prepped as per the instructions for use in the lab.No anomalies were noted when the device was taken out of the package.There was no difficulty experienced in prepping the device.The access site was the femoral arteries.The intended procedure/target lesion was the inferior vena cava for filter removal.There was no difficulty tracking through the vasculature and no unusual force was used at any time during the procedure.The device was removed intact from the patient.The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 18054601 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 factors such as exposing the distal tip of the catheter sheath introducer to the fixation barbs on the optease filter 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, ¿the csi is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.Possible complications include, but are not limited to air embolism, infection, intimal tear, hematoma at the puncture site, perforation of the vessel wall, thrombus formation.¿ 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 35CM 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: 13546796
• Report Number: 9616099-2022-05352
• Device Sequence Number: 20089554
• Product Code: DYB
• UDI-Device Identifier: 10705032000390
• UDI-Public: 10705032000390
• 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): 02/16/2022

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: 08/31/2024
• Device Model Number: 401835M
• Device Catalogue Number: 401835M
• Device Lot Number: 18054601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 02/16/2022
• Date Device Manufactured: 09/24/2021
• 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: BRITE TIP SHEATH; OPTEASE
• Patient Sex: Unknown