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

Model Number	400SMTXSFT0410
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	06/17/2020
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 anterior inferior cerebellar artery (aica) using penumbra smart coils (smart coils), non-penumbra coils and a non-penumbra microcatheter.During the procedure, the physician placed smart coils and non-penumbra coils in the target vessel using the microcatheter.While attempting to advance the next smart coil out of its introducer sheath, the smart coil became stuck in the middle of its introducer sheath and was unable to advance after several attempts were made to do so.Therefore, the smart coil was removed.The procedure was completed using another smart coil.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 pusher assembly was kinked approximately 34.0 and 90.0 cm from the proximal end.An unknown substance was on the pusher assembly proximity marker beneath the introducer sheath near the friction lock.The embolization coil was intact with the pusher assembly.Minor offset coil winds were present on the embolization coil.Conclusions: evaluation of the returned smart coil revealed that an unknown substance was on the pusher assembly proximity marker beneath the introducer sheath near the friction lock.During functional testing, the smart coil was able to be re-sheathed from it returned position within the introducer sheath with resistance due to the unknown substance.The unknown substance was removed, and the smart coil was able to advance through its introducer sheath and a demonstration microcatheter without an issue.The origin of the unknown substance could not be determined; however, the unknown substance likely contributed to the reported complaint.Further evaluation revealed pusher assembly kinks and minor offset coil winds.These damages were likely incidental to the reported complaint.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.Section h.Box 6.Conclusions code 1: 4316-the investigation findings do not lead to a clear conclusion about the root cause of unknown substance.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10257803
• Report Number: 3005168196-2020-00921
• Device Sequence Number: 2964051
• Product Code: HCG
• UDI-Device Identifier: 00814548015408
• UDI-Public: 00814548015408
• Combination Product (Y/N): Y
• Initial Reporter Country: PL
• 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): 06/17/2020
• 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: 07/15/2024
• Device Model Number: 400SMTXSFT0410
• Device Catalogue Number: 400SMTXSFT0410
• Device Lot Number: F91797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 85
• Date Report Sent to FDA: 01/01/2005