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

Catalog Number	67005400
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18160638 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, there was a crack on the hub of a 6f.070 extra back-up (xb) 3.5 x 100cm vista brite tip guiding catheter.There were no reports of patient injury.The staff had discovered the defect and had presented it to the physician.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 Manufacturer Narrative
There was a crack on the hub of a 6f.070 extra back-up (xb) 3.5 x 100cm vista brite tip guiding catheter.There were no reports of patient injury.The staff had discovered the defect and had presented it to the physician.The product was returned for analysis.A non-sterile catheter 6f.070 xb 3.5 100cm was received coiled inside a plastic bag.The catheter was thoroughly inspected focusing on the luer hub area observing that the unit presented several kinks located approximately at 25, 45, and 85cm from the distal tip.The luer hub does not present any damages or anomalies.Per dimensional analysis measurement results were found within specification.A product history record (phr) review of lot 18160638 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿luer hub cracked¿ was not confirmed by analysis of the returned device as visual and dimensional analysis was performed successfully.The exact cause of the reported event could not be determined.However, several kinks were observed on the returned unit.The dimensional analysis results of the od and id were found within specification.The exact cause of the observed damages could not be conclusively determined during the evaluation.Procedural factors and handling process may have contributed to the failure as reported.According to the safety information in the instructions for use, ¿inspect the guiding catheter before use to verify that its size, shape and condition are suitable for the specific procedure.Warning: do not use a guiding catheter that has been damaged in any way.If damage is detected, replace with an undamaged guiding catheter.¿ the reported event could not be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time at this time.

• Brand Name: VISTA BRITE TIP
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS US CORP.; 14021 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14021 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 17022178
• Report Number: 9616099-2023-06507
• Device Sequence Number: 6872796
• Product Code: DQY
• UDI-Device Identifier: 20705032020166
• UDI-Public: (01)20705032020166(17)251031(10)18160638
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2023

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: 10/31/2025
• Device Catalogue Number: 67005400
• Device Lot Number: 18160638
• 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: 05/04/2023
• Supplement Date Received by Manufacturer: 05/31/2023; 08/15/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/24/2023; 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown