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

Catalog Number	400SMTSTD1260
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2018
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 in the right internal carotid artery (ica) using penumbra smart coils (smart coils).During the procedure, the physician successfully advanced nineteen coils and four smart coils to the target vessel using a non-penumbra microcatheter.While attempting to advance a smart coil within its introducer sheath as the twenty-fourth coil, the physician felt resistance and could not advance the smart coil any further.The smart coil was therefore removed and was not used in the procedure.The procedure was completed using a new smart coil, other coils, and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intake at the proximal end of the pusher assembly.The pusher assembly had bends and kinks approximately 12.0 cm, 74.5 cm, 78.0 cm, 91.5 cm, 133.0 cm and 137.5 cm from the proximal end.The pusher assembly mid-joint was proximal to the introducer sheath friction lock.The embolization coil was undamaged and intact with the distal detachment tip (ddt) of the pusher assembly.Conclusions: evaluation of the returned smart coil revealed the pusher assembly mid-joint was proximal to the introducer sheath friction lock.The inner diameter (id) of the friction lock is smaller than the rest of the introducer sheath allowing the sheath to seat properly on the pusher assembly.If the friction lock is moved distal to the pusher assembly mid-joint, resistance may be encountered when attempting to advance the smart coil out of its introducer sheath.During functional testing, the introducer sheath was reseated on the pusher assembly mid-joint and was subsequently able to advance through a demonstration microcatheter without resistance.The reported complaint could not be confirmed.Further evaluation revealed bends and kinks along the pusher assembly.These damages may have been due to advancing the device against resistance or during packaging for return to penumbra.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.Please note that the following section is being corrected: describe event or problem.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal carotid artery (ica) using penumbra smart coils (smart coils).During the procedure, the physician successfully advanced nineteen coils and four smart coils to the target vessel using a non-penumbra microcatheter.While attempting to advance the twenty-fourth coil, a smart coil, from its initial position within its introducer sheath, the physician felt resistance and was unable to advance the smart coil at all.The smart coil was therefore removed and was not used in the procedure.The procedure was completed using a new smart coil, 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: 8218667
• Report Number: 3005168196-2019-00017
• Device Sequence Number: 1631509
• Product Code: HCG
• UDI-Device Identifier: 00814548014449
• UDI-Public: 00814548014449
• 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): 12/06/2018
• 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: 07/30/2022
• Device Catalogue Number: 400SMTSTD1260
• Device Lot Number: F78424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Date Report Sent to FDA: 01/01/2005