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

Model Number	400SMTXSFT0408
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the smart coil pusher assembly was fractured approximately 2.5 cm from the proximal end.The remainder of the pusher assembly, including the braided shaft and hypo tube, were undamaged.The pull-wire was contained within the distal detachment tip (ddt) alignment feature.The ddt was occluded with dried blood.The smart coil embolization coil was no longer attached to the pusher assembly and was not returned for investigation.The returned smart coil detachment handle was undamaged.After all visual and functional analysis, a small amount of bleach was used to clean the ddt of coagulated blood.No abnormalities were observed when the clotted blood was cleared.Conclusions: evaluation of the returned smart coil revealed a broken pusher assembly and a detached embolization coil.It was reported that the embolization coil could not be detached during the procedure; therefore additional manipulation may have occurred between the event and when the smart coil was returned which resulted in detachment.The cause of the reported complaint could not be determined due to the damage done to the pusher assembly, and the embolization coil having been detached before return to penumbra.Evaluation of the detachment handle revealed a fully functional device.The detachment handle likely did not cause or contribute to the reported complaint.Penumbra coils and handles 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle) and, a non-penumbra microcatheter.During the procedure, the physician advanced a smart coil in the ruptured aneurysm and used the handle to detach it; however, the smart coil failed to detach.It was reported that only one to three millimeters of the black alignment zone (pet lock) was separated, and the smart coil failed to detach after multiple attempts of using the handle.The physician then attempted to manually detach the smart coil by hand and with a needle driver, including removing part of the pusher assembly for greater access to the pull wire but the smart coil would not detach.Therefore, the smart coil was removed.The procedure was completed 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: 9856665
• Report Number: 3005168196-2020-00404
• Device Sequence Number: 11621177
• Product Code: HCG
• UDI-Device Identifier: 00814548015392
• UDI-Public: 00814548015392
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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): 02/28/2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2024
• Device Model Number: 400SMTXSFT0408
• Device Catalogue Number: 400SMTXSFT0408
• Device Lot Number: F93759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• 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: 02/28/2020
• Initial Report FDA Received Date: 03/19/2020
• 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