MAUDE Adverse Event Report: CORDIS CORPORATION SI BRITE TIP F5 55CM; INTRODUCER, CATHETER

Model Number	401555M
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	07/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the 5f 55cm brite tip catheter sheath introducer (csi) was inserted but the distal end frayed.The damage was noticed when the device was being inserted into the patient.There was no reported damage to the packaging.The product was stored in the box within the lab.No anomalies were noted when the device was removed from the package.The device was not removed from packaging by pulling on the hub.The device was prepped according to the instructions for use (ifu).There was no difficulty noted during prep.The femoral artery was used for access during the procedure.The vessel was not pre-dilated.The intended target/lesion was the internal iliac.There was no resistance/friction noted while advancing through the sheath.The puncture site did not have any visible plaque/calcium.The case was completed after use of a non-cordis device.There was no reported patient injury.The device was not returned for analysis.A product history record (phr) review of lot 17999412 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported 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 reported event could not be conclusively determined.It is possible that procedural factors, such as operator technique, may have contributed to the reported event.According to the ifu, which is 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.¿ additionally, users are clinically trained to recognize any signs of damage to devices and to discontinue the procedure and exchange the device for a new one.Without the return of the device for analysis, it is difficult to make a clinical conclusion whether the reported event is related to the device based on the limited information available.Neither the phr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
Event or Problem Description
As reported, the 5f 55cm brite tip catheter sheath introducer (csi) was inserted but the distal end frayed.There was no reported patient injury.The damage was noticed when the device was being inserted into the patient.There was no reported damage to the packaging.The product was stored in the box within the lab.No anomalies were noted when the device was removed from the package.The device was not removed from packaging by pulling on the hub.The device was prepped according to the instructions for use (ifu).There was no difficulty noted during prep.The femoral artery was used for access during the procedure.The vessel was not pre-dilated.The intended target/lesion was in the internal iliac.There was no resistance/friction noted while advancing through the sheath.The puncture site did not have any visible plaque/calcium.The case was completed after use of a non-cordis device.The device will not be returned for analysis as it was discarded at the hospital.

• Brand Name: SI BRITE TIP F5 55CM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12275955
• Report Number: 9616099-2021-04761
• Device Sequence Number: 4663983
• Product Code: DYB
• UDI-Device Identifier: 20705032000212
• UDI-Public: (01)20705032000212(17)231231(10)17999412
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2021

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: 12/31/2023
• Device Model Number: 401555M
• Device Catalogue Number: 401555M
• Device Lot Number: 17999412
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1