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

Model Number	400SMTHXSFT1H04
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	11/15/2019
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: 3005168196-2019-02353.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the superior mesenteric artery (sma) using penumbra smart coils (smart coils), non-penumbra coils, and a non-penumbra microcatheter.During the procedure, the physician successfully implanted a coil into the target vessel using the microcatheter.When a smart coil was advanced approximately 2 cm into the microcatheter, the physician encountered strong resistance and the smart coil was subsequently removed.Upon advancement of the next smart coil approximately 3 cm outside of the microcatheter, the physician encountered resistance and this smart coil was also removed.The procedure was completed using another smart coil and the same microcatheter.There was no report of an adverse effect to the patient.After the procedure, it was reported that the first smart coil was able to advance outside of the microcatheter against strong resistance when tested on the back table.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the superior mesenteric artery (sma) using penumbra smart coils (smart coils), non-penumbra coils, and a non-penumbra microcatheter.During the procedure, the physician successfully implanted a coil into the target vessel using the microcatheter.When a smart coil was advanced approximately 2 cm into the microcatheter, the physician encountered strong resistance and the smart coil was subsequently removed.Upon advancement of the next smart coil approximately 3 cm out of the distal tip of the microcatheter, the physician encountered resistance and this smart coil was also removed.The procedure was completed using another smart coil and the same microcatheter.There was no report of an adverse effect to the patient.After the procedure, it was reported that the first smart coil was able to advance outside of the microcatheter against strong resistance when tested on the back table.
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 #01 mfr 3005168196-2019-02352.Results: the pet lock was broken and separated approximately 0.2 cm apart on the proximal end of the pusher assembly.The embolization coil was intact with the pusher assembly and had offset coil winds at its proximal end.Conclusions: evaluation of the first returned smart coil revealed that the embolization coil had offset coil winds on its proximal end.If the introducer sheath is not properly aligned inside the hub of the microcatheter prior to advancement, resistance may be encountered, and damage such as this may occur.During functional testing, the smart coil was able to be advanced through its introducer sheath without issue, but the embolization coil was unable to be advanced through the hub of a demonstration microcatheter due to the offset coil winds on its proximal end.Further investigation revealed that the pet lock was broken and separated.This damage was likely incidental to the complaint.Evaluation of the second returned smart coil revealed offset coil winds along the length of its embolization coil.If the embolization coil is forcefully manipulated against resistance, damage such as this may occur.The non-penumbra microcatheter used in the complaint was not returned for evaluation; therefore, the root cause of the resistance was unable to be determined.During the functional testing, the returned smart coil was able to be advanced through its introducer sheath and a demonstration microcatheter with resistance due to the kinks on its pusher assembly.The kinks on the pusher assembly were likely incidental to the complaint and may have occurred during packaging for return to penumbra.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.This report is associated with mfr report number: 3005168196-2019-02353.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9490863
• Report Number: 3005168196-2019-02352
• Device Sequence Number: 1215187
• Product Code: HCG
• UDI-Device Identifier: 00814548015675
• UDI-Public: 00814548015675
• 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): 11/21/2019
• 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: 04/09/2024
• Device Model Number: 400SMTHXSFT1H04
• Device Catalogue Number: 400SMTHXSFT1H04
• Device Lot Number: F89523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 02/13/2020
• 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