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

Catalog Number	400SMTSTD1260
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, the physician was unable to advance a smart coil within its introducer sheath, despite flushing the coil and attempting multiple times.The pusher assembly of the smart coil then became kinked due to the force exerted while trying to advance it.Therefore, the smart coil was removed.The procedure was then completed using new smart coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly mid-joint was proximal to the introducer sheath friction lock and it was fractured approximately 138.0 cm from the proximal end.The pusher assembly had kinks at approximately 136.0 cm and 137.0 cm from the proximal end.The embolization coil was detached from the pusher assembly within the introducer sheath.The device was fractured; therefore, no functional testing was performed.Conclusions: evaluation of the returned smart coil revealed the pusher assembly mid-joint proximal to the introducer sheath friction lock.If the pusher assembly mid-joint is positioned proximal to the introducer sheath friction lock, resistance may be experienced when attempting to advance the smart coil.Further evaluation revealed a kinked and fractured pusher assembly and a detached embolization coil.This pusher damage is likely a result of forcefully advancing the device against the resistance created by the mid-joint and friction lock.If the pusher assembly becomes fractured, it will allow the pull wire to retract from the distal detachment tip and detach the embolization coil.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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8202617
• Report Number: 3005168196-2018-02532
• Device Sequence Number: 18881302
• Product Code: HCG
• UDI-Device Identifier: 00814548014449
• UDI-Public: 00814548014449
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• 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): 11/30/2018
• 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: 07/13/2022
• Device Catalogue Number: 400SMTSTD1260
• Device Lot Number: F78154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 03/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Date Report Sent to FDA: 01/01/2005