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

Catalog Number	400SMTXSFT1H02
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was broken on the proximal end of the pusher assembly.The pull wire was retracted approximately 7.5 cm from the proximal end of the pusher assembly.The pull wire was present within the distal detachment tip (ddt) of the pusher assembly and the embolization coil was not detached.The embolization coil was undamaged.Conclusion: evaluation of the returned smart coil revealed a device with a separated proximal pet lock and a fractured pull wire.A detachment attempt using a handle was reported in the complaint which likely caused the proximal pet lock to separate.Despite this detachment attempt, the pull wire remained within the pusher assembly distal detachment tip (ddt).During functional testing, the pull wire was found to have fractured within the pusher assembly.This pull wire fracture likely prevented the handle from retracting the pull wire from the ddt, which is required to detach the embolization coil from the pusher assembly.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.This report is associated with mfr report number: 3005168196-2018-02459.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the posterior communicating artery (pcom) using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).During the procedure, the physician successfully placed two coils in the target vessel using a non-penumbra microcatheter.The physician then advanced a smart coil to the target location, however, was unable to detach the coil on the first attempt using the handle.Although the physician observed that the black alignment zone was separated in half, the smart coil failed to detach.Therefore, the physician pulled the pull wire of the smart coil pusher assembly in an attempt to manually detach the smart coil; however, the smart coil did not detach.Therefore, the smart coil was removed.The procedure was completed using other 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: 8179305
• Report Number: 3005168196-2018-02456
• Device Sequence Number: 1332495
• Product Code: HCG
• UDI-Device Identifier: 00814548015224
• UDI-Public: 00814548015224
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 11/19/2018
• 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: 07/06/2021
• Device Catalogue Number: 400SMTXSFT1H02
• Device Lot Number: F70506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• 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: 11/19/2018
• Initial Report FDA Received Date: 12/19/2018
• 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