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

Model Number	IMP-05
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The imp-05 device was being used to embolize the ima.Prior to device implantation, it was found that only the anchor coil was present and that the foam plug component was missing.This device is being returned by the complainant to shape memory medical so that further investigation may occur.A follow-up report will be filed once more information related to this device malfunction is known.
Event or Problem Description
The physician planned to use an imp-05 device to embolize an ima.However, prior to using the device, it was checked under fluoroscopy where it was found that only the anchor coil was present and not the foam plug portion of the device.To confirm this, the physician pushed the device out of the introducer, onto the bench, using a guidewire and the foam plug with markerband portion of the device could not be found.There was no impact to the patient as the procedure was completed using another imp-05 device.
Event or Problem Description
The physician planned to use an imp-05 device to embolize an ima.However, prior to using the device, it was checked under fluoroscopy where it was found that only the anchor coil was present and not the foam plug portion of the device.To confirm this, the physician pushed the device out of the introducer, onto the bench, using a guidewire and the foam plug with markerband portion of the device could not be found.There was no impact to the patient as the procedure was completed using another imp-05 device.
Additional Manufacturer Narrative
Review of lot history records uncovered no unresolved issues or anomalies identified related to the device.The imp-05 device was returned to shape memory medical for additional investigational information.A root cause of the reported incident could not be confirmed as examination under a microscope identified no manufacturing issues which could be related to the reported event.

• Brand Name: IMPEDE EMBOLIZATION PLUG
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SHAPE MEMORY MEDICAL; 807 aldo ave.; suite 109; santa clara CA 95054 2252
• Manufacturer (Section G): SHAPE MEMORY MEDICAL; 807 aldo ave.; suite 109; santa clara CA 95054 2252
• Manufacturer Contact: meghan reu ; 807 aldo ave.; suite 109; santa clara, CA 95054-2252 ; 4086495175
• MDR Report Key: 13061127
• Report Number: 3013353964-2021-00005
• Device Sequence Number: 1608627
• Product Code: KRD
• UDI-Device Identifier: 00810041650009
• UDI-Public: 00810041650009
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

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: 11/07/2022
• Device Model Number: IMP-05
• Device Catalogue Number: IMP-05
• Device Lot Number: F20043001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2021
• Supplement Date Received by Manufacturer: 11/25/2021
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2020
• 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