MAUDE Adverse Event Report: CORDIS CORPORATION CATH F4 INF IM 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	538460
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	12/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
This case was received from an competitor's company and while attempting to catheterize the ligament of marshall¿s (lom) after an af ablation procedure, a perforation of the coronary sinus occurred with the guide.An echography revealed the perforation and a pericardiocentesis was performed to stabilize the patient.There were no abbott catheters in the heart, the af procedure was finished.A 4f infiniti catheter contributed to the event.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
This case was received from a competitor's company.While attempting to catheterize the ligament of marshall¿s (lom) after an af ablation procedure, a perforation of the coronary sinus occurred with the guide.An echography revealed the perforation and a pericardiocentesis was performed to stabilize the patient.There were no competitor's catheters in the heart, the af procedure was finished.A 4f infiniti catheter contributed to the event.The product was not returned for analysis and a product history record (phr) review could not be performed because the lot number for this product is unknown.Without the return of the device or images for analysis, the reported event ¿perforation¿ could not be confirmed.Procedural/handling factors such as vessel characteristics and excessive catheter manipulation may have contributed to the reported event.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿do not use open or damaged packages.To prevent damage to the catheter tip during removal from the package, grasp the hub and gently withdraw the catheter.Treat all 4f catheters and smaller french sizes with ultimate care.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.Procedures requiring percutaneous catheter introduction should not be attempted by physicians unfamiliar with the possible complications.Complications may occur at any time during or after the procedure.Possible complications include but are not limited to the following: air embolism, hematoma at the puncture site, infection, and perforation of the vessel wall.¿ based on the information available, 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.

• Brand Name: CATH F4 INF IM 100CM
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13338673
• Report Number: 9616099-2022-05310
• Device Sequence Number: 4164702
• Product Code: DQO
• UDI-Device Identifier: 10705032014885
• UDI-Public: 10705032014885
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 538460
• Device Catalogue Number: 538460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/28/2021
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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