MAUDE Adverse Event Report: MARMAID MEDICAL A/S D*CLOT® HD ROTATIONAL THROMBECTOMY SYSTEM

Model Number	T10106065
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Type of Reportable Event	Serious Injury
Event or Problem Description
Distributor reported that end user executed a procedure to remove a clot, but the wire went into the wall of the vein and perforated it.The end user had to stent the puncture.
Additional Manufacturer Narrative
The local sa distributor reported an end user had an incident while removing a clot from a patient where the wall was punctured and required an extra surgical step to fix the puncture by stenting it.This was the first time the user had used this type of device, and during this first use, performed the procedure without contacting the distributor to assist nor watch the first case to support.As instructed in the ifu, the device is to be positioned correctly prior to activating the device and during activation, the device catheter should be slowly withdrawn.It was determined that the most likely cause of this incident was user error as, when the device was turned on (active), the device catheter was moved or pushed forward, allowing the device to hit and then penetrate the wall.Any new relevant information received will be updated to this record.

• Common Device Name: ROTATIONAL THROMBECTOMY SYSTEM
• Manufacturer (Section D): MARMAID MEDICAL A/S; frydensbergvej 25; stenloese, hovedstaden 3660 ; DA 3660
• Manufacturer (Section G): MERMAID MEDICAL; frydensbergvej 25; stenløse, 3660 ; DA 3660
• Manufacturer Contact: matthew genzman ; 8033 cooper creek blvd; unit 106; university park, FL 34201 ; 9418672129
• MDR Report Key: 16929889
• Report Number: 3007146453-2023-00001
• Device Sequence Number: 20543246
• Product Code: QEW
• UDI-Device Identifier: 15711055004333
• UDI-Public: 15711055004333
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/21/2023
• Device Model Number: T10106065
• Device Catalogue Number: T10106065
• Device Lot Number: S2208045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 05/15/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown