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

Model Number	400SMTSFT3H06
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2020-00048.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).During the procedure, the physician advanced a smart coil to the target vessel and attempted to detach it using the handle, but the handle was unable to detach the smart coil.Therefore, the smart coil was removed.The physician then re-advanced the smart coil to the target vessel and attempted to detach it again using the handle, but the same issue occurred.Therefore, the smart coil was removed and not used for the remainder of the procedure.The procedure was completed using four other smart coils and the same handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was broken on the proximal end of its pusher assembly.The pusher assembly was kinked in multiple locations.The embolization coil was intact with its pusher assembly and had offset coil winds.The distal shaft braided section was exposed approximately 10.0 cm.The pull wire was intact with the distal detachment tip (ddt).Conclusions: evaluation of the returned smart coil revealed a broken and retracted pet lock.If a detachment handle is attached to the proximal end of the pusher assembly an actuated, damage such as a broken and retracted pet lock may occur.During the functional test, a demonstration handle was attached to the proximal end of the returned pusher assembly and actuated.However, the embolization coil did not detach from its pusher assembly.Further evaluation of the returned smart coil revealed that the distal shaft braided section was exposed, and the pull wire remained inside the ddt.If the braided shaft is exposed and an attempt is made to detach the coil, the pusher assembly may shorten, and the pull wire will not retract out of the ddt.If this occurs, the embolization coil will likely not detach.The root cause of these damages could not be determined.Penumbra coils are visually 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.Box 6.Conclusions code 1: 4316 ¿ the investigation findings do not lead to a clear conclusion about the cause of the smart coil not being able to detach.This report is associated with mfr report number: 3005168196-2020-00048.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9602968
• Report Number: 3005168196-2020-00047
• Device Sequence Number: 584866
• Product Code: HCG
• UDI-Device Identifier: 00814548017006
• UDI-Public: 00814548017006
• 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,Followup
• Report Date (Section B): 12/23/2019
• 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: 12/04/2021
• Device Model Number: 400SMTSFT3H06
• Device Catalogue Number: 400SMTSFT3H06
• Device Lot Number: F73015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 03/27/2020
• 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