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

Catalog Number	400SMTXSFT2H04
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/25/2019
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 in the clinoid segment of the internal carotid artery (ica) to treat a subarachnoid hemorrhage (sah) using penumbra smart coils (smart coils).During the procedure, the physician successfully placed a smart coil in the ruptured aneurysm using a non-penumbra microcatheter.The physician then was unable to advance another smart coil from its initial position within its introducer sheath and, therefore, the smart coil was removed.The physician attempted to advance the smart coil out of its introducer sheath on the back table; however, the smart coil would not advance and its pusher assembly became kinked.The procedure was then completed using additional 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 penumbra smart coil (smart coil) pusher assembly.The pusher assembly was kinked at approximately 136.0 cm and 137.0 cm from the proximal end.The smart coil pusher assembly mid-joint was proximal to the introducer sheath friction lock.The embolization coil was intact with the pusher assembly and was undamaged.A 0.0159¿ ring gauge was unable to pass through the kink location on the pusher assembly.During functional testing, the smart coil was properly re-sheathed into its introducer sheath and the embolization coil was able to advance through its introducer sheath and the demonstration microcatheter.Resistance was experienced when the kink was advanced through the introducer sheath and microcatheter.Conclusions: evaluation of the returned smart coil confirmed kinks on its pusher assembly.Further investigation revealed that the pusher assembly mid-joint was proximal to introducer sheath friction lock.If the mid-joint was retracted proximal to the introducer sheath friction lock, resistance will be experienced during subsequent attempts to advance the device.If the smart coil is forcefully advanced against resistance, damage such as kinking may occur.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: 8544891
• Report Number: 3005168196-2019-00776
• Device Sequence Number: 16580444
• Product Code: HCG
• UDI-Device Identifier: 00814548015323
• UDI-Public: 00814548015323
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 03/25/2019
• 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: 04/09/2022
• Device Catalogue Number: 400SMTXSFT2H04
• Device Lot Number: F80445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Date Report Sent to FDA: 01/01/2005