MAUDE Adverse Event Report: CORDIS CORPORATION BRITE TIP RADIANZ; INTRODUCER, CATHETER

Model Number	687280135
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: as reported, the hemostasis valve on a 135 cm brite tip radianz guiding sheath came off as the physician was removing the sheath.The difficulties encountered during the insertion process were reflective of the fact that the patient had small vessels.There was slight resistance encountered during the withdrawal process.There were no reports of patient injury.There were attempts at reconnecting the removable valve, without success.The case was completed without other products and no other issues were found.The vessel dilator was not snapped into place at the hub at the time of removal.The access site vessels had no calcification or tortuosity.The device was flushed prior to use.The device/packaging was not damaged prior to utilizing the device.The user is trained to the device.The device was stored and prepped according to the instructions for use (ifu).Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The product was not returned for analysis.A product history record (phr) review of lot 18106460 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device or images for analysis, the reported customer events ¿hemostasis valve/hub- loosened/detached-during use (brite tip radianz only), catheter sheath introducer (csi)- insertion difficulty, catheter sheath introducer (csi)-withdrawal difficulty and hemostasis valve/hub-damaged during use¿ could not be confirmed.Procedural/handling factors may have contributed to the reported events.Failure to ensure the hemostasis valve was securely attached to the guiding sheath hub may have contributed to the detached hemostasis valve.The withdrawal difficulties may have been related to patient¿s reported small vessel size.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, ¿prior to use, confirm that the catheter guiding sheath size is appropriate for the access vessel to be used.Check to make sure the hemostasis valve is securely connected to the catheter guiding sheath hub.¿ 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.
Event or Problem Description
As reported, the hemostasis valve on a 135 cm brite tip radianz guiding sheath came off as the physician was removing the sheath.The difficulties encountered during the insertion process were reflective of the fact that the patient had small vessels.There was slight resistance encountered during the withdrawal process.There were no reports of patient injury.There were attempts at reconnecting the removable valve, without success.The case was completed without other products and no other issues were found.The vessel dilator was not snapped into place at the hub at the time of removal.The access site vessels had no calcification or tortuosity.The device was flushed prior to use.The device/packaging was not damaged prior to utilizing the device.The user is trained to the device.The device was stored and prepped according to the instructions for use (ifu).Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device was not returned for evaluation.
Additional Manufacturer Narrative
Phr was reopened for revisions.Complaint conclusion: as reported, the hemostasis valve on a 135 cm brite tip radianz guiding sheath came off as the physician was removing the sheath.The difficulties encountered during the insertion process were reflective of the fact that the patient had small vessels.There was slight resistance encountered during the withdrawal process.There were no reports of patient injury.There were attempts at reconnecting the removable valve, without success.The case was completed without other products and no other issues were found.The vessel dilator was not snapped into place at the hub at the time of removal.The access site vessels had no calcification or tortuosity.The device was flushed prior to use.The device/packaging was not damaged prior to utilizing the device.The user is trained to the device.The device was stored and prepped according to the instructions for use (ifu).The product was not returned for analysis.A product history record (phr) review of lot 18106460 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device or images for analysis, the reported customer events ¿hemostasis valve/hub (brite tip radianz only)-loosened/detached, catheter sheath introducer (csi)- insertion difficulty, csi-withdrawal difficulty and hemostasis valve/hub-damaged¿ could not be confirmed.The exact cause of these events cannot be determined with the information available.The hemostasis valve may not have been securely tightened in place prior to insertion, which may have resulted to its detachment.It was reported the patient has small vessels and this could have contributed to the insertion and withdrawal difficulties.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, ¿select an appropriately sized catheter guiding sheath.Inspect the system contents for any signs of damage; do not use if any damage is present.Check to make sure the hemostasis valve is securely connected to the catheter guiding sheath hub.¿ 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.A risk assessment to address events of hemostasis valve/hub (brite tip radianz only)-loosened/detached has already been initiated.No further action will be taken at this time.

• Brand Name: BRITE TIP RADIANZ
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14021 nw 60th 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: 16483473
• Report Number: 9616099-2023-06297
• Device Sequence Number: 12078048
• Product Code: DYB
• UDI-Device Identifier: 20705032081211
• UDI-Public: (01)20705032081211(17)240430(10)18106460
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023

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: 04/30/2024
• Device Model Number: 687280135
• Device Catalogue Number: 687280135
• Device Lot Number: 18106460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 03/04/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2022
• 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