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

Model Number	400SMTXSFT0203
Medical Device Problem Codes	Separation Failure (2547); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The embolization coil was implanted in the patient; however, the pusher assembly is available for return.A final report will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-02519.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the m2 segment of the middle cerebral artery (mca) using a penumbra smart coil (smart coil) and a penumbra smart coil detachment handle (handle).During the procedure, the physician advanced the smart coil in the target vessel and attempted to detach it using the handle; however, the smart coil failed to detach.The physician then attempted to manually detach the smart coil but was unsuccessful.Therefore, the physician decided to remove the smart coil.However, while retracting the smart coil, it unintentionally detached inside the microcatheter.The physician then pushed the detached smart coil into the aneurysm using a wire.The procedure was completed using other coils.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the m2 segment of the middle cerebral artery (mca) using a penumbra smart coil (smart coil) and a penumbra smart coil detachment handle (handle).During the procedure, the physician advanced the smart coil in the target vessel and attempted to detach it using the handle; however, the smart coil failed to detach.The physician then attempted to manually detach the smart coil but was unsuccessful.Therefore, the smart coil was removed.The procedure was completed using other coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil confirmed that the embolization coil was intact with its pusher assembly.Evaluation revealed that the pet lock was separated, and the pull wire was fractured off the proximal end of the pusher assembly.This damage likely occurred during manual attempts to detach the embolization coil.Further evaluation revealed multiple kinks throughout the length of the pusher assembly, and offset coil winds along the length of the embolization coil.This damage was incidental to the reported complaint.Due to the returned condition, the device could not be functionally tested, and the root cause of the reported complaint could not be determined.Penumbra products are visually 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 the reported complaint due to the return condition.This report is associated with mfr report number: 3005168196-2021-02519.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12780290
• Report Number: 3005168196-2021-02518
• Device Sequence Number: 5942681
• Product Code: HCG
• UDI-Device Identifier: 00814548015279
• UDI-Public: 00814548015279
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2021
• 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: 11/16/2025
• Device Model Number: 400SMTXSFT0203
• Device Catalogue Number: 400SMTXSFT0203
• Device Lot Number: F102085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2020
• 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: Female
• Date Report Sent to FDA: 01/01/2005