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

Catalog Number	401611M
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the distal end of a 6f 11cm brite tip sheath got frayed after it was inserted.The device was removed from the patient and replaced with a new brite tip sheath to complete the procedure.There was no reported patient injury.The target lesion was the iliac artery.The vessel level of angulation, calcification and tortuosity is none.The vessel level of stenosis is 100%.The product was stored and handled according to the instructions for use (ifu).There were no visible signs of device/package damage prior to use.There were no anomalies noted when the device was taken out of the package.There was no excessive force applied to the device during withdrawal from package.The device was not resterilized.The device was prepped according to instructions for use (ifu).The device was prep normally.There were no anomalies noted during or after the device was prepped.An ipsilateral approach was made.There was no unusual force used at any time during the procedure.There was no excess force used during insertion.The product was removed intact (in one piece) from the patient.The device was not returned for analysis due to the patient¿s infectious disease.A product history record (phr) review of lot 17796887 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 issue experienced could not be determined.Based on the information available for review, it is not possible to determine what may have contributed to the issue experienced since the customer reported there was no excessive force used during use of the device.However, procedural/handling factors are possible since this reported issue typically occurs after application of excessive force during insertion into the patient.According to 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 information available for review 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 distal end of a brite tip sheath got frayed after it was inserted.The device was removed from the patient and replaced with a new brite tip sheath to complete the procedure.There was no reported patient injury.The target lesion was the iliac artery.The vessel level of angulation, calcification and tortuosity is none.The vessel level of stenosis id 100%.The product was stored and handled according to the instructions for use (ifu).There were no visible signs of device/package damage prior to use.There were no anomalies noted when the device was taken out of the package.There was no excessive force applied to the device during withdrawal from package.The device was not resterilized.The device was prepped according to instructions for use (ifu).The device was prep normally.There were no anomalies noted during or after the device was prepped.An ipsilateral approach was made.There was no unusual force used at any time during the procedure.There was no excess force used during insertion.The product was removed intact (in one piece) from the patient.The device will not be returned for analysis as it was discarded due to patient¿s infectious disease.

• Brand Name: SI BRITE TIP 6F 11CM STR
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8404733
• Report Number: 9616099-2019-02769
• Device Sequence Number: 13947084
• Product Code: DYB
• UDI-Device Identifier: 20705032000236
• UDI-Public: 20705032000236
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K984500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/08/2019

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: 06/30/2021
• Device Catalogue Number: 401611M
• Device Lot Number: 17796887
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BRITE TIP SHEATH