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

Catalog Number	400SMTSFT4H10
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2018
Type of Reportable Event	Malfunction
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 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: 3005168196-2018-02464.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).During the procedure, the physician attempted to advance the first smart coil into the target vessel using a non-penumbra microcatheter, and felt strong resistance.The smart coil only advanced approximately 9cm into the microcatheter and became stuck inside.Therefore, the smart coil was removed.The physician then advanced a second smart coil into the target vessel but could not detach it using the handle and it retreated 2cm into the microcatheter.A second attempt was then made to detach the smart coil and the same issue occurred and the smart coil retreated 1cm into the microcatheter.The physician then manually detached the coil, however, part of the smart coil remained in the microcatheter.Subsequently, the pusher assembly of the smart coil was used to advance the smart coil into the target vessel.The procedure was completed using additional coils and the same microcatheter.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: 8187664
• Report Number: 3005168196-2018-02470
• Device Sequence Number: 19329718
• Product Code: HCG
• UDI-Device Identifier: 00814548017051
• UDI-Public: 00814548017051
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2018
• 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: 03/05/2022
• Device Catalogue Number: 400SMTSFT4H10
• Device Lot Number: F74800
• 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: 11/20/2018
• Initial Report FDA Received Date: 12/20/2018
• 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