MAUDE Adverse Event Report: CORDIS CORPORATION SI BRITE TIP 6F 55CM STR; INTRODUCER, CATHETER

Model Number	401655M
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During use of the 6f brite tip catheter sheath introducer (csi), the physician could not remove the sheath from patient because the sheath kinked.There was no patient injury.The device is available for analysis.
Additional Manufacturer Narrative
This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
During use of the 6f brite tip catheter sheath introducer (csi), the physician could not remove the sheath from patient because the sheath kinked.There was no patient injury.The product was not returned for analysis and a lot number was not provided; therefore, a product history record (phr) review could not be performed.Without the return of the device or images for analysis, the reported customer event ¿catheter sheath introducer (csi)- withdrawal difficulty¿ and ¿catheter sheath introducer (csi)- kinked/bent - in patient¿ could not be confirmed.Procedural/handling factors 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, ¿remove the sheath when clinically indicated by placing compression on the vessel above the puncture site, and slowly withdraw the csi.Discard the sheath appropriately.Important: upon removing any csi, aspirate via the sideport extension to collect any fibrin that may have been deposited.¿ based on the information available 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 6F 55CM STR
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12960561
• Report Number: 9616099-2021-05141
• Device Sequence Number: 14804947
• Product Code: DYB
• UDI-Device Identifier: 10705032000277
• UDI-Public: 10705032000277
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K984500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2021

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 Model Number: 401655M
• Device Catalogue Number: 401655M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown