MAUDE Adverse Event Report: CORDIS CORPORATION SI BRITE TIP 6F 23CM STR; INTRODUCER, CATHETER

Model Number	401623M
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	05/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the hemostasis valve of a brite tip sheath introducer (si brite tip 6f 23cm str) came off during an endovascular therapy (evt) case as a non-cordis balloon catheter was being removed.There was no reported patient injury.The target lesion was the iliac artery.There was mild calcification and moderate vessel tortuosity the percentage stenosis was not provided.It is unknown if the device was being used for a chronic total occlusion.The product was stored, handled and prepped according to the instructions for use (ifu).There was no damage noticed to the device prior to opening the package.There was no difficulty removing the device from the sterile packaging nor any difficulty experienced in prepping the device.There were no anomalies noted prior to inserting the device into the patient and no excess force used at any time.The sheath was not kinked or had been twisted/torqued prior to the separation.The patient did not require hospitalization nor the hospitalization was extended as a result of this event.The device is expected to be return for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17983609 presented no issues during the manufacturing process that could be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, the hemostasis valve of a brite tip sheath introducer (si brite tip 6f 23cm str) came off during an endovascular therapy (evt) case as a non-cordis balloon catheter was being removed.There was no reported patient injury.The target lesion was the iliac artery.There was mild calcification and moderate vessel tortuosity.The percentage stenosis was not provided.It is unknown if the device was being used for a chronic total occlusion.The product was stored, handled, and prepped according to the instructions for use (ifu).There was no damage noticed to the device prior to opening the package.There was no difficulty removing the device from the sterile packaging nor any difficulty experienced in prepping the device.There were no anomalies noted prior to inserting the device into the patient and no excess force used at any time.The sheath was not kinked or had been twisted/torqued prior to the separation.The patient did not require hospitalization and the hospitalization was not extended because of this event.One non-sterile si brite tip 6f 23cm str unit was received for analysis.The unit was thoroughly inspected with special attention focused on the hub and hemostasis valve.No anomalies were observed.A product history record (phr) review of lot 17983609 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer, ¿hemostasis valve/hub - separated - during use¿ was not confirmed since the hemostasis valve was received properly assembled with no separations noted.The exact cause of the reported event cannot be conclusively determined with the available information and the fact that the device was returned with no anomalies noted.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, ¿to exchange catheters, slowly withdraw the catheter from the csi and repeat the insertion procedure.¿ based on the information available and the phr review, 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 23CM STR
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 14595375
• Report Number: 9616099-2022-05671
• Device Sequence Number: 5935459
• Product Code: DYB
• UDI-Device Identifier: 10705032000246
• UDI-Public: 10705032000246
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2022

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: 10/31/2023
• Device Model Number: 401623M
• Device Catalogue Number: 401623M
• Device Lot Number: 17983609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/12/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER (0.035INCH 10MM ARMADA ABBOTT)
• Patient Sex: Unknown