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

Model Number	400SMTXSFT0203
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2020
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: 3005168196-2020-00307.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the m1 of the middle cerebral artery (mca) using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle) and a non-penumbra microcatheter.During the procedure, the physician successfully deployed and detached nine smart coils into the target vessel using the handle.The physician then advanced the tenth smart coil in the target using the microcatheter and attempted to detach it using the handle; however, the smart coil failed to detach.The physician made two additional attempts; however, the smart coil did not detach.Afterwards, the physician attempted to manually detach the smart coil; however, it would not detach.Therefore, the entire system was removed.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was separated on the proximal end of the pusher assembly.The pusher assembly had bends on its proximal end.An unknown substance was within the hub of the non-penumbra microcatheter.Conclusions: evaluation of the returned smart coil could not determine the root cause of the reported complaint due to the return condition.The smart coil was returned within a non-penumbra microcatheter, and upon removal of the smart coil from the microcatheter, it was noticed that the embolization coil was not intact with the pusher assembly; therefore, the device could not be functionally tested and it is unable to determine when the embolization coil became detached.Further evaluation revealed a separated pet lock and bends along the proximal end of the pusher assembly.These damages were likely a result of the attempts to detach the embolization coil during the procedure.Penumbra coils are 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: 3005168196-2020-00307.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9795431
• Report Number: 3005168196-2020-00306
• Device Sequence Number: 2574215
• Product Code: HCG
• UDI-Device Identifier: 00814548015279
• UDI-Public: 00814548015279
• 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): 02/14/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/24/2024
• Device Model Number: 400SMTXSFT0203
• Device Catalogue Number: 400SMTXSFT0203
• Device Lot Number: F91331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Date Report Sent to FDA: 01/01/2005