MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. SURFACER®; REVERSE CENTRAL VENOUS RECANALIZATION SYSTEM

Catalog Number	600200/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	07/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a procedure, the patient experienced an arterial perforation requiring intervention and also suffered a stroke post procedure due to physician failure to properly anticoagulant the patient.The physician states that the device was successfully advanced from the patient's right femoral vein to the site of the occlusion in the svc.The device was then advanced through the targeted occlusion, and the tip of the device was advanced superior to the right clavicle.The tip of the device and the exit site target were correctly aligned under fluoroscopy and the needle wire was advanced and exteriorized with the assistance of an #11 blade and a pair of hemostats.The peel away sheath was then advanced over the wire to the patient.Hemostats were placed at the proximal end of the sheath clamping the wire in place.The physician then locked the wire in place on the device and proceeded to pull the sheath inside the patient.The physician then administered contrast through the sheath and observed vascular extravasation due to perforation of the artery.The device was then removed from the patient entirely and the interventional cardiology team was urgently called to assist.The team successfully deployed vascular stents to repair the arterial perforation.The physician believes he inadvertently perforated the right innominate artery while manipulating the surfacer device.He also believes his actions and failure to push heparin during the rest of procedure may have caused the patient to stroke.The event was not a result of the device malfunction.The device performed as intended.The patient was treated with benadryl pre-procedure due to allergies to vancomycin and various contrast agents.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: SURFACER®
• Common Device Name: REVERSE CENTRAL VENOUS RECANALIZATION SYSTEM
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 17393786
• Report Number: 1721504-2023-00065
• Device Sequence Number: 12245026
• Product Code: QJH
• UDI-Device Identifier: 00860003451601
• UDI-Public: 00860003451601
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 600200/A
• Device Lot Number: BVT041923-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown