MAUDE Adverse Event Report: CORDIS CORPORATION CARDIO DIAGNOSTIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	CP0210
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	10/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the curve of a 6f pigtail infiniti diagnostic catheter within a customized 6f infinity diagnostic catheter multipack came off.An unknown device was used as a replacement.For evaluation.The device was not in touch with the patient and there were no reported patient injuries.There was no apparent damage when unpacking the catheter and the device was placed at the table.When the physician picked up the device to be used, the distal tip came off.The device was stored per the instructions for use (ifu).The multipack included a pig-tail catheter, a judkins left (jl) catheter and a judkins right (jr) catheter.The pigtail was the only catheter with issues.There was no damage to the packaging.The device was discarded and will not be returned.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly.Complaint conclusion: as reported, the curve of a 6f pigtail infiniti diagnostic catheter within a customized 6f infinity diagnostic catheter multipack came off.An unknown device was used as a replacement.The device was not in touch with the patient and there were no reported patient injuries.There was no apparent damage when unpacking the catheter and the device was placed at the table.When the physician picked up the device to be used, the distal tip came off.The device was stored per the instructions for use (ifu).The multipack included a pig-tail catheter, a judkins left (jl) catheter and a judkins right (jr) catheter.The pigtail was the only catheter with issues.There was no damage to the packaging.The reported event by the customer as ¿brite tip/distal tip separated¿ was not confirmed since the device was not returned for analysis and no images were provided.The exact cause of the issue experienced could not be determined.Without the return of the device and based on the limited information available for review, it is not possible to determine what factors may have contributed to the reported event.As the issue occurred prior to patient insertion, handling and/or storage factors may have contributed to the issue described.According to the instructions for use (ifu), which is not intended as a mitigation, the catheter should be stored in a cool, dark, dry place.To prevent damage to the catheter during removal from the package, grasp the hub (as was done in this case) and withdraw the catheter.Based on the information available for review, there is no indication to suggest that the reported failure could be related to the design or manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.
Event or Problem Description
As reported, the curve of a 6f pigtail infiniti diagnostic catheter within a customized 6f infinity diagnostic catheter multipack came off.An unknown device was used as a replacement.The device was not in touch with the patient and there were no reported patient injuries.There was no apparent damage when unpacking the catheter and the device was placed at the table.When the physician picked up the device to be used, the distal tip came off.The device was stored per the instructions for use (ifu).The multipack included a pig-tail catheter, a judkins left (jl) catheter and a judkins right (jr) catheter.The pigtail was the only catheter with issues.There was no damage to the packaging.The device was discarded and will not be returned.

• Brand Name: CARDIO DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 20652156
• Report Number: 9616099-2024-00377
• Device Sequence Number: 8247538
• Product Code: DQO
• UDI-Device Identifier: 10705032025942
• UDI-Public: (01)10705032025942(17)270630(10)18340505
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K970854
• 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): 11/18/2024

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
• Device Catalogue Number: CP0210
• Device Lot Number: 18340505
• 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: 10/17/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2024
• 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: 6F JL INFINITI DIAGNOSTIC CATHETER; 6F JR INFINITI DIAGNOSTIC CATHETER; UNKNOWN CATHETER
• Patient Sex: Unknown