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

Catalog Number	400SMTXSFT1H02
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils), a smart coil detachment handle (handle), and a non-penumbra microcatheter.It was reported that the patient¿s anatomy was tortuous.During the procedure, the physician advanced the smart coil into the target location and attempted to detach the smart coil using the handle; however, the smart coil did not detach.Next, the physician attempted to manually detach the smart coil using a hemostat without success.Therefore, the physician decided to remove the smart coil.While retracting, the smart coil unintentionally detached within the microcatheter.Therefore, the microcatheter containing the smart coil was removed and the smart coil was flushed out from the microcatheter.The procedure was completed using non-penumbra coils.There was no report of an adverse effect.
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Evaluation of the returned smart coil confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the pet lock was separated, and the pull wire was retracted from the pusher assembly distal tip.This indicated that the embolization coil was detached as intended.Due to the returned condition, the smart coil was unable to be functionally tested for the reported detachment issue; therefore, the root cause of the detachment issue could not be determined.Further evaluation revealed kinks on the pusher assembly and offset coil winds on the embolization coil.This damage was likely incidental and occurred during packaging for the device return.Penumbra coils 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 unintentional detachment.

• 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: 16968328
• Report Number: 3005168196-2023-00238
• Device Sequence Number: 5580589
• Product Code: HCG
• UDI-Device Identifier: 00814548015224
• UDI-Public: 814548015224
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023
• 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 Catalogue Number: 400SMTXSFT1H02
• Device Lot Number: F113437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2023
• 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: 04/25/2023
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2022
• 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 Age: 80 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005