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

Model Number	400SMTXSFT1H04
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	09/27/2020
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: 3005168196-2020-01815.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle) and non-penumbra microcatheter.During the procedure, the physician advanced a smart coil into the target location using the microcatheter and attempted to detach it using the handle; however, the smart coil failed to detach.Therefore, the smart coil and handle were removed.The procedure was completed using a new smart coil and new handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pusher assembly was fractured on its proximal end.The pusher assembly was kinked approximately 4.0 and 8.5 cm from its proximal end.The pull wire was inside the distal detachment tip (ddt) and the embolization coil was intact with its pusher assembly and had offset coil winds.There was no visible damage to the braided shaft.Conclusions: evaluation of the returned handle revealed a functional device.During the functional test, the handle was functionally tested on a handle fixture and passed within specification.The handle was then used to detach a demonstration coil without an issue.Evaluation of the returned smart coil confirmed that the embolization coil was not detached from the pusher assembly.Further evaluation revealed that the proximal end of the pusher assembly was fractured off and the pull wire was inside the ddt.This damage was likely incidental to the reported complaint.However, this damage prevented the smart coil from being functionally tested.Therefore, the root cause of the reported issue could not be determined.Penumbra handles are functionally tested during incoming inspection by quality.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of smart coil detachment failure.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: 1.3005168196-2020-01815.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10727896
• Report Number: 3005168196-2020-01816
• Device Sequence Number: 3345574
• Product Code: HCG
• UDI-Device Identifier: 00814548015248
• UDI-Public: 00814548015248
• Combination Product (Y/N): Y
• Initial Reporter Country: PO
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020
• 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: 01/27/2025
• Device Model Number: 400SMTXSFT1H04
• Device Catalogue Number: 400SMTXSFT1H04
• Device Lot Number: F95910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 10/23/2020
• 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
• Date Report Sent to FDA: 01/01/2005