MAUDE Adverse Event Report: CORDIS CORPORATION CATH F6INF TL JR 3.5 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	534619T
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a fracture was found on a 6f infiniti judkins right 3.5 100cm guiding catheter during right coronary angiography.It was successfully removed from the patient's vessel.It is unknown if the device will be returned for evaluation.The hospital reported it as an adverse event to the china nmpa directly.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18025539 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.
Additional Manufacturer Narrative
As reported, a fracture was found on a 6f infiniti judkins right 3.5 100cm guiding catheter during right coronary angiography.It was successfully removed from the patient's vessel.There was no reported patient injury.Multiple attempts to obtain additional information was made without success.The product was not returned for analysis.A product history record (phr) review of lot 18025539 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter (body/shaft) cracked in patient¿ could not be confirmed as the device was not returned for analysis.The exact cause of the event experienced by the customer could not be determined.Based on the limited information available for review, it is not possible to determine what factors may have contributed to issue experienced; however, procedural/handling factors are likely.Although not intended as a mitigation of risk, the information for safety within the instructions for use (ifu) is provided in the product¿s labeling with the intent to make the user aware of the risks.As cautioned in the ifu, ¿to prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.Exercise care when removing guidewires from multiple-curve catheters.Before use, flush all devices entering a blood vessel with sterile heparinized saline or a similar isotonic solution.Keep the catheter filled with either flushing solution or contrast medium while the catheter is in the vascular system and consider the use of systemic heparinization.Forcibly aspirate and flush the catheter with heparinized saline solution at least once every two minutes.¿ neither the phr review nor the information available suggest a design or manufacturing related cause for the reported event.Therefore, no corrective/preventive action will be taken at this time.

• Brand Name: CATH F6INF TL JR 3.5 100CM
• 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 ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15140738
• Report Number: 9616099-2022-05871
• Device Sequence Number: 7323623
• Product Code: DQO
• UDI-Device Identifier: 10705032014175
• UDI-Public: 10705032014175
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K970854
• 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
• Report Date (Section B): 08/10/2022

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: 534619T
• Device Catalogue Number: 534619T
• Device Lot Number: 18025539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 08/10/2022
• Date Device Manufactured: 05/27/2021
• 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