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

Model Number	400SMTHXSFT0203
Medical Device Problem Codes	Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2020
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the paraclinoid of the right internal carotid artery (ica) using a penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, while advancing the smart coil halfway through the microcatheter, the physician experienced resistance and had difficulty advancing the smart coil further; therefore, the smart coil was removed.The procedure was completed using additional smart coils and non-penumbra coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up mfr report 3005168196-2020-00331: 1.Section b.Box 4.Date of this report.Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 51.0 cm from the proximal end.The embolization coil was intact with the pusher assembly and had offset coil winds along its length.Conclusions: evaluation of the returned smart coil revealed offset coil winds on its embolization coil.If the device is forcefully advanced against resistance, damage such as the offset coil winds may occur.The non-penumbra microcatheter used in the procedure was not returned for evaluation; therefore, the root cause of the resistance could not be determined.During the functional testing, the smart coil was able to be advanced thorough a demonstration microcatheter with resistance due to the pusher assembly kink.The pusher assembly kink was likely incidental to the complaint and may have occurred during advancement 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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9819375
• Report Number: 3005168196-2020-00331
• Device Sequence Number: 2205334
• Product Code: HCG
• UDI-Device Identifier: 00814548015705
• UDI-Public: 00814548015705
• 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): 02/20/2020
• 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: 02/14/2023
• Device Model Number: 400SMTHXSFT0203
• Device Catalogue Number: 400SMTHXSFT0203
• Device Lot Number: F81910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Date Report Sent to FDA: 01/01/2005