MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL; HCG, KRD

Model Number	400SMTHXSFT1H02
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2020-02260.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle cerebral artery (mca) using penumbra smart coils (smart coils) a penumbra smart coil detachment handle (handle) and two non-penumbra microcatheters.During the procedure, the physician placed three smart coils and sixteen non-penumbra coils into the target vessel using a microcatheter.The physician then advanced another smart coil into the target vessel and used the handle to detach it; however, the smart coil failed to detach.Therefore, the physician manually detached the smart coil by breaking the pusher assembly of the smart coil and pulling the pull wire.Afterwards, while advancing another smart coil through the middle of the microcatheter the physician experienced resistance.Therefore, the smart coil was removed.The procedure was completed using two additional smart coils, the same handle, and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pusher assembly was fractured on its proximal end and was damaged for approximately 11.0 cm on its proximal end.The embolization coil was detached from the pusher assembly.Conclusions: evaluation of the first returned smart coil revealed that the pusher assembly was damaged and fractured on its proximal end, and the embolization coil was detached.This was likely a result of the reported manual detachment during the procedure.The smart coil could not be functionally tested; therefore, the root cause of the reported complaint could not be determined.Evaluation of the second returned smart coil revealed offset coil winds along the embolization coil.If the device is forcefully advanced against resistance, damage such as this may occur.During functional testing, resistance was experienced while attempting to advance the smart coil through the hub of a demonstration microcatheter due to the offset coil wind, and the smart coil could not advance any further.The root cause of resistance experienced during the procedure could not be determined.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of device's difficulty detaching.This report is associated with mfr report number: 3005168196-2020-02260.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10999067
• Report Number: 3005168196-2020-02259
• Device Sequence Number: 19723329
• Product Code: HCG
• UDI-Device Identifier: 00814548015651
• UDI-Public: 00814548015651
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2020
• Report Date (Section F): 01/01/2005

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: 01/25/2025
• Device Model Number: 400SMTHXSFT1H02
• Device Catalogue Number: 400SMTHXSFT1H02
• Device Lot Number: F95788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/15/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 12/13/2020
• Supplement Report FDA Received Date: 01/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005