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

Model Number	67005600
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18115622 presented no issues during the manufacturing process that could be related to the event reported.The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 6f.070 xb 4 100cm vista brite tip guiding catheter was found fractured in the medial segment.There was no reported patient injury.The device is expected to be returned for evaluation.
Additional Manufacturer Narrative
As reported, a 6f.070 xb 4 100cm vista brite tip guiding catheter was found fractured in the medial segment during prep.The device was not used in the patient.Another 6f vista brite tip xb4 catheter was used to complete the procedure.There was no reported patient injury.The product was stored and handled according to the instructions for use (ifu).There was no device damage noticed prior to opening the package.The device was prepped per the instructions for use (ifu) and there was no difficulty experienced in prepping the device.Neither the product nor any or any of the other devices used with it had been re-sterilized.The device was not returned for evaluation.A product history record (phr) review of lot 18115622 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter-cracked¿ could not be confirmed or further clarified without the return of the device(s).Procedural/handling and or shipping factors may have contributed to the reported event.Information for safety is provided in the products labeling with the intent to make the user aware of the risks and warns the user to not use a guiding catheter that has been damaged in any way.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿inspect the catheter upon removal from packaging to verify that is undamaged, if damage is detected do not use the catheter and select another one.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, a 6f.070 xb 4 100cm vista brite tip guiding catheter was found fractured in the medial segment during prep.The device was not used in the patient.Another 6f vista brite tip xb4 catheter was used to complete the procedure.There was no reported patient injury.The product was stored and handled according to the instructions for use (ifu).There was no device damage noticed prior to opening the package.The device was prepped per the instructions for use (ifu) and there was no difficulty experienced in prepping the device.Neither the product nor any or any of the other devices used with it had been re-sterilized.Multiple attempts were made to obtain the return status of the device; however, the device was not returned for evaluation.

• Brand Name: VISTA BRITE TIP
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, florida 33014 ; 7863138372
• MDR Report Key: 16879688
• Report Number: 9616099-2023-06485
• Device Sequence Number: 5822579
• Product Code: DQY
• UDI-Device Identifier: 20705032020210
• UDI-Public: (01)20705032020210(17)250531(10)18115622
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2023

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: 67005600
• Device Catalogue Number: 67005600
• Device Lot Number: 18115622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 05/29/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 06/02/2023
• Date Device Manufactured: 06/06/2022
• 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