MAUDE Adverse Event Report: CORDIS CORPORATION SI BRITE TIP F5 11CM; INTRODUCER, CATHETER

Model Number	401511M
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18034791 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 5f brite tip csi was introduced into the patient; however, when removing the dilator, the hemostatic valve was pulled off.This caused blood to pulsate out of the sheath.The physician switched to a 6f brite tip sheath and the case was completed without any further issues.There was no reported patient injury.There was no damage to the package.The product was stored in the lab properly according to the instructions for use (ifu).There were no anomalies noted when the device was removed from the packaging.The device was prepped per the ifu without difficulty.The sheath was not torqued against resistance and no excess force was used or needed.There as no difficulty tracking the csi through the vasculature.There was no stent noted to be near the puncture site.The device will be returned for evaluation.
Event or Problem Description
As reported, a 5f brite tip csi was introduced into the patient; however, when removing the dilator, the hemostatic valve was pulled off.This caused blood to pulsate out of the sheath.The physician switched to a 6f brite tip sheath and the case was completed without any further issues.There was no reported patient injury.There was no damage to the package.The product was stored in the lab properly according to the instructions for use (ifu).There were no anomalies noted when the device was removed from the packaging.The device was prepped per the ifu without difficulty.The sheath was not torqued against resistance and no excess force was used or needed.There as no difficulty tracking the csi through the vasculature.There was no stent noted to be near the puncture site.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, a 5f brite tip catheter sheath introducer (csi) was introduced into the patient however, the hemostatic valve was pulled off while removing the dilator.This caused blood to pulsate out of the sheath.The physician switched to a 6f brite tip sheath, and the case was completed without any further issues.There was no reported patient injury.There was no damage to the package.The product was stored in the lab properly according to the instructions for use (ifu).There were no anomalies noted when the device was removed from the packaging.The device was prepped per the ifu without difficulty.The sheath was not torqued against resistance and no excess force was used or needed.There was no difficulty tracking the csi through the vasculature.A stent was not noted near the puncture site.One non-sterile si brite tip 5f 11cm unit was received for analysis.The device was received with the vessel dilator inserted in the cannula.Additionally, the gasket was not completely assembled to the hub.No other anomalies were noted during visual analysis.Microscopic analysis was performed, and no anomalies were noted to the gasket or hemostatic valve however, the hub presented with damages that impeded the gasket from assembling correctly.This finding is considered to be related to the manufacturing process.The reported event, ¿hemostasis valve/hub ¿ separated - during use¿ was confirmed.Microscopic analysis revealed damages on the ring hub.No damages or anomalies were noted to the gasket or the hemostatic valve, which ruled out procedural and/or handling factors as a cause of the separation.The reported condition is considered related to the manufacturing process as confirmed through the product evaluation.Therefore, the event has been escalated and a risk assessment has been initiated.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: SI BRITE TIP F5 11CM
• 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: 12689474
• Report Number: 9616099-2021-04999
• Device Sequence Number: 4986068
• Product Code: DYB
• UDI-Device Identifier: 10705032000178
• UDI-Public: (01)10705032000178(17)240531(10)18034791
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,Followup,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 Expiration Date: 05/31/2024
• Device Model Number: 401511M
• Device Catalogue Number: 401511M
• Device Lot Number: 18034791
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 12/13/2021; 12/15/2021
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 12/13/2021; 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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
• Patient Sex: Unknown