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

Model Number	400SMTXSFT0202
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
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.This report is associated with mfr report number: 3005168196-2020-02170.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the m1 segment of the middle cerebral artery (mca) using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).During the procedure, while the physician started preparing and flushing a smart coil, it was noticed that the smart coil would not advance at all from its initial position within its introducer sheath on the back table.The issue with the smart coil was found prior to use, therefore, the smart coil was not used in the procedure.The physician then advanced another smart coil into the target location and attempted to detach it using a handle; however, the smart coil failed to detach.Therefore, the smart coil and handle were removed.The procedure was completed using additional coils and a new handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the proximal end of the pusher assembly was kinked.The embolization coil was undamaged and intact with the pusher assembly.Conclusions: evaluation of the returned smart coil revealed that the embolization coil was intact with the pusher assembly.Further evaluation revealed that the pusher assembly was kinked on its proximal end and the pull wire was not present.The root cause of this damage could not be determined; however, if the pusher assembly is kinked, the pull wire may become pinned and prevent the pull wire from being retracted.Evaluation of the returned handle revealed an undamaged, functional device.The handle was tested on a test fixture and performed within specification.Further evaluation revealed a piece of pet was within the nose cone funnel.This was likely a result of the detachment attempt during the procedure.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.This report is associated with mfr report number: 1.3005168196-2020-02170.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10943371
• Report Number: 3005168196-2020-02169
• Device Sequence Number: 16748945
• Product Code: HCG
• UDI-Device Identifier: 00814548015262
• UDI-Public: 00814548015262
• Combination Product (Y/N): Y
• Initial Reporter Country: GR
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020
• 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: 06/25/2025
• Device Model Number: 400SMTXSFT0202
• Device Catalogue Number: 400SMTXSFT0202
• Device Lot Number: F98557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Date Report Sent to FDA: 01/01/2005