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

Catalog Number	400SMTSFT0820
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pusher assembly was fractured on the proximal end.The pusher assembly was kinked throughout its length.The embolization coil was intact with the pusher assembly distal detachment tip (ddt).Offset coil winds were present along the embolization coil.Conclusions: evaluation of the returned penumbra smart coil (smart coil) revealed the pusher assembly was fractured on the proximal end, the pull tube was not present, the pull wire was within the pusher assembly ddt and the embolization coil was intact with the ddt.If the smart coil is forcefully mishandled extreme angles, damage such as a kink may occur.Further manipulation of a kinked device may result in a fracture.If the pusher assembly and pull tube fractures, the pull wire cannot be retracted when an attempt is made to detach the coil, and the embolization coil will remain intact with the pusher assembly.Evaluation of the returned handle confirmed a piece of the pet lock from the smart coil pusher assembly was stuck in the handle.If the handle is manipulated at extreme angles with the pusher handle within the nose cone it may cause the pusher assembly to become damaged within the handle mechanism.Repeated actuation of the handle may also contribute to a piece of the pusher assembly becoming stuck within the handle mechanism.The device was functionally tested after removing the pet and performed within specification.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are 100% visually inspected and functionally tested during incoming quality inspection.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 left internal carotid artery (ica) using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).During the procedure, the physician advanced a smart coil into the target vessel using a non-penumbra microcatheter and attempted to detach it using a handle; however, the smart coil failed to detach.It was also reported that the physician noticed approximately six centimeters of the inner wire was pulled out by the handle and was sticking out from the proximal end of the microcatheter.Therefore, the smart coil was removed.The procedure was completed using new smart coils, a new handle 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: 9369349
• Report Number: 3005168196-2019-02174
• Device Sequence Number: 2224367
• Product Code: HCG
• UDI-Device Identifier: 00814548014753
• UDI-Public: 00814548014753
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• 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): 10/28/2019
• 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: 04/06/2024
• Device Catalogue Number: 400SMTSFT0820
• Device Lot Number: F89429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• 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: 10/28/2019
• Initial Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Date Report Sent to FDA: 01/01/2005