MAUDE Adverse Event Report: CORDIS US. CORPORATION VISTA BRITE TIP; CATHETER, PERCUTANEOUS

Model Number	67012600
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18123927 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 hair was found in the inner package of 6f.070 extra back-up right ca 100cm vista brite tip guiding catheter when it was delivered to the hospital.Therefore, making it unusable.There was no reported patient injury.The device will be returned for evaluation.
Additional Manufacturer Narrative
This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, a hair was found in the inner package of 6f.070 extra back-up right ca 100cm vista brite tip guiding catheter when it was delivered to the hospital.Therefore, making it unusable.There was no reported patient injury.The device will be returned for evaluation.The device was returned for analysis.A unit of ¿6f.070 xb rca 100cm¿ was received for analysis inside its sterile package.The device was unpacked and was placed at one metallic tray to be inspected and it was found what appears to be a hair.A thorough inspection was performed observing that the unit does not present any damages or anomalies.A ftir was performed to the foreign material found.The contaminant found inside the packaging of the finished product appeared to be suspected hair on which infrared analysis was performed.Taking into account the shape of the contaminant and the biological composition obtained by infrared analysis, it is confirmed that this contaminant is a hair.A product history record (phr) review of lot 18123927 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event of ¿packaging/pouch/box ¿ foreign material - in sterile package¿ was confirmed during analysis of the returned device.As the exact cause of the event could not conclusively be determined the event was escalated per the risk management process and a risk assessment has been opened to further investigate the issue.
Event or Problem Description
As reported, a hair was found in the inner package of 6f.070 extra back-up right ca 100cm vista brite tip guiding catheter when it was delivered to the hospital.Therefore, making it unusable.There was no reported patient injury.The device will be returned for evaluation.

• Brand Name: VISTA BRITE TIP
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS US. CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US. 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: 16554762
• Report Number: 9616099-2023-06356
• Device Sequence Number: 14783957
• Product Code: DQY
• UDI-Device Identifier: 20705032020654
• UDI-Public: (01)20705032020654(17)250531(10)18123927
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K021593
• 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): 07/18/2023

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: 05/31/2025
• Device Model Number: 67012600
• Device Catalogue Number: 67012600
• Device Lot Number: 18123927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/06/2023
• Supplement Date Received by Manufacturer: 03/31/2023; 07/12/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 04/25/2023; 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2022
• 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