MAUDE Adverse Event Report: SHAPE MEMORY MEDICAL INC. IMPEDE EMBOLIZATION PLUG; VASCULAR EMBOLIZATION PLUG

Model Number	IMP-10
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The physician was delivering an imp-10 device using a 7fr apt medical guide catheter to embolize a right ovarian vein.During device deployment, the imp-10 anchor coil formed in a straight configuration, instead of a helical shape.Because of this, the physician chose to remove the catheter containing the device.After removing the catheter from the patient, the physician ran a guidewire through the catheter lumen and the delivery introducer containing the imp-10 device emerged from the catheter.Subsequent attempts to advance the device were unsuccessful.Thereafter the case was completed using other embolic devices.No adverse event to the patient was reported.It was additionally stated that the temperature indicator label on the imp-10 device packaging had activated.
Additional Manufacturer Narrative
Right ovarian vein was being embolized using an imp-10 device.The physician was using a 7fr apt medical guide catheter to deliver the imp-10.During device deployment, the imp-10 anchor coil formed in a straight configuration, instead of a helical shape.Because of this, the physician chose to remove the catheter containing the device.After removing the catheter from the patient, the physician ran a guidewire through the catheter lumen and the delivery introducer containing the imp-10 device emerged from the catheter.Subsequent attempts to advance the device were unsuccessful.Thereafter the case was completed using other embolic devices.No adverse event to the patient was reported.A review of the lot history record and lot release report identified no quality issues related to device performance.A benchtop investigation did not occurr because no device was returned to shape memory medical.Based on smm's review of the information received, the most probable root cause for this event is being attributed to the physicians use of the imp-10 device in spite of the fact that the temperature indicator label located on the device pouch had activated.The impede ifu states that if the temperature indicator label shows the temperature has been exceeded (i.E.The indicator dot is black), the device should not be used as the plug component of the device may have expanded impacting delivery performance.This abnormal use coupled with the physician having difficulty advancing the device through the introducer likely led to luer hub detaching from the introducer tubing and the anchor coil remaining straight and not forming a coil as expected.Smm complaint reference number: (b)(4).

• Brand Name: IMPEDE EMBOLIZATION PLUG
• Common Device Name: VASCULAR EMBOLIZATION PLUG
• Manufacturer (Section D): SHAPE MEMORY MEDICAL INC.; 807 aldo avenue; suite 109; santa clara CA 95054
• Manufacturer (Section G): SHAPE MEMORY MEDICAL INC.; 807 aldo avenue; suite 109; santa clara CA 95054
• Manufacturer Contact: meghan reu ; 807 aldo avenue; suite 109; santa clara, CA 95054
• MDR Report Key: 16464852
• Report Number: 3013353964-2023-00003
• Device Sequence Number: 20149454
• Product Code: KRD
• UDI-Device Identifier: 00810041650023
• UDI-Public: 00810041650023
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2023

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: 11/04/2023
• Device Model Number: IMP-10
• Device Catalogue Number: IMP-10
• Device Lot Number: F21102901E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• 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