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

Catalog Number	400SMTSFT0203
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	02/20/2019
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 internal carotid artery (ica) using penumbra smart coils (smart coils).During the procedure, the physician successfully advanced the first smart coil into the target location using a non-penumbra microcatheter.While attempting to advance the second smart coil through its introducer sheath, the physician experienced resistance and reported that he was unable to advance the coil past its initial position.The smart coil was then removed and was not used in the procedure.The procedure was completed using 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 intact on the proximal end of the pusher assembly.The smart coil pusher assembly mid-joint was proximal to the introducer sheath friction lock.The embolization coil was undamaged and intact with the pusher assembly.The pusher assembly was able to advance through a 0.0159¿ ring gauge and the mid-joint od was within specification.Conclusions: evaluation of the returned smart coils revealed the pusher assembly mid-joint was retracted into the introducer sheath friction lock.If the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock during use, resistance may be experienced while attempting to advance the device.During the functional testing, the smart coil was properly re-sheathed and able to be advanced through its introducer sheath and a demonstration microcatheter without an issue.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: 8487744
• Report Number: 3005168196-2019-00628
• Device Sequence Number: 1870726
• Product Code: HCG
• UDI-Device Identifier: 00814548015118
• UDI-Public: 00814548015118
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019
• 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: 11/09/2022
• Device Catalogue Number: 400SMTSFT0203
• Device Lot Number: C06882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 05/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Date Report Sent to FDA: 01/01/2005