MAUDE Adverse Event Report: CORDIS CORPORATION SI BRITE TIP 10F 11CM; INTRODUCER, CATHETER

Model Number	401011M
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: a 10f 11cm brite tip catheter sheath introducer (csi) was used when an unknown cover stent was implanted.The distal end of the brite tip got frayed upon insertion.There was no reported patient injury.The device was stored, handled and prepped per the instructions for use (ifu).The target lesion was the iliac artery.The device was used for a chronic total occlusion (total occlusion >3 months).There was no calcification of the lesion and no vessel tortuosity.There was 100% vessel stenosis.There were no anomalies noted when the product was removed from the package or during prep.There was no resistance met while advancing the device.There was no resistance met while withdrawing the device.The procedure was completed with an unknown sheath.Additional procedural details were requested but were unknown.The product was not returned for analysis.A product history record (phr) review of lot 17839281 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 could not be determined.Excessive force and vessel characteristics of 100% stenosis may have contributed to the reported event.According to the instructions for use, which is not intended to mitigate 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.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 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, a 10f 11cm brite tip catheter sheath introducer was used when an unknown cover stent was implanted.However, the distal end of the brite tip got frayed when it was inserted.There was no injury to the patient.The device stored, handled and prepped per the instructions for use (ifu).The target lesion was the iliac artery.The device was used for a chronic total occlusion (total occlusion >3 months).There was no calcification of the lesion, no vessel tortuosity but with 100% stenosis.There were no anomalies noted when the product was removed from the package and during prep.There was no resistance met while advancing the device.There was no resistance met while withdrawing the device.The procedure was completed with an unknown new sheath.Other additional procedural details were requested but were unknown.The device will not be returned for analysis because it was discarded due to infectious disease.

• Brand Name: SI BRITE TIP 10F 11CM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes 33014
• MDR Report Key: 9452290
• Report Number: 9616099-2019-03396
• Device Sequence Number: 13989848
• Product Code: DYB
• UDI-Device Identifier: 20705032000113
• UDI-Public: 20705032000113
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2019

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: 01/31/2022
• Device Model Number: 401011M
• Device Catalogue Number: 401011M
• Device Lot Number: 17839281
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1