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

Model Number	400SMTXSFT011H
Medical Device Problem Codes	Migration (4003); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 3005168196-2020-00213.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the posterior communicating arteries (pcom) using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), and a non-penumbra stent retriever.During the procedure, the physician advanced the smart coil to the aneurysm of the target vessel.The smart coil was then detached using the handle, and it was initially thought to have been completely detached.However, as the pusher assembly of the smart coil was being retracted, the smart coil was pulled out of the aneurysm, unintentionally detached, and went downstream.Subsequently, the physician attempted to retrieve the smart coil using a stent retriever but was unsuccessful.The smart coil was then left in the distal middle cerebral artery (mca).The procedure ended at this point, and no coils were placed in the aneurysm.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9735336
• Report Number: 3005168196-2020-00214
• Device Sequence Number: 352901
• Product Code: HCG
• UDI-Device Identifier: 00814548015170
• UDI-Public: 00814548015170
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/26/2020
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 400SMTXSFT011H
• Device Catalogue Number: 400SMTXSFT011H
• Was Device Available for Evaluation?: No
• 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: 01/26/2020
• Initial Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Date Report Sent to FDA: 01/01/2005