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

Model Number	400SMTHXSFT0103
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	11/30/2020
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle meningeal artery (mma) using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, three smart coils were implanted into the target location and detached using the handle.While attempting to implant the fourth smart coil, it would not detach.The physician attempted to manually detach the coil without success.Upon withdrawal of the pusher assembly, the physician noticed that the smart coil had detached inside the microcatheter.Therefore, the pusher wire was used to push the smart coil into the target location.The procedure was completed using four other coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil pusher assembly confirmed that the embolization coil was detached from the pusher assembly.Further evaluation revealed that the pusher assembly was damaged on its proximal end and the pull wire was retracted out of the pusher assembly.This damage was likely a result of the detachment attempts made during the procedure.Based on the returned condition, the root cause of the reported complaint could not be determined.Evaluation of the returned handle revealed an undamaged, functional device.The handle was tested on a test fixture and performed within specification.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are 100% visually inspected and functionally tested during incoming quality inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text : placeholder.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11084941
• Report Number: 3005168196-2020-02362
• Device Sequence Number: 3785866
• Product Code: HCG
• UDI-Device Identifier: 00814548015620
• UDI-Public: 00814548015620
• 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): 12/02/2020
• 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: 10/14/2023
• Device Model Number: 400SMTHXSFT0103
• Device Catalogue Number: 400SMTHXSFT0103
• Device Lot Number: F86450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 02/11/2021
• 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