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

Catalog Number	400SMTXSFT0406
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.Bends were present throughout the pusher assembly.The introducer sheath was in its initial position on the smart coil.The embolization coil was undamaged and intact with the pusher assembly.The pusher assembly mid-joint was measured with a ring gauge and the introducer sheath friction lock was measured with a pin gauge and both were within specification.Conclusions: evaluation of the returned smart coil revealed a functional device.During functional testing, resistance was experienced while unseating the introducer sheath from the pusher assembly mid-joint initially.The smart coil was then advanced through its introducer sheath and a demonstration microcatheter without an issue.Further evaluation revealed bends along the pusher assembly.These bends 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left posterior communicating artery (pcom) using penumbra smart coils (smart coils).During the procedure, the physician reported that the smart coil would not advance through its introducer sheath.Therefore, the smart coil was removed and was not used in the procedure.The procedure was completed using another smart coil.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: 9191891
• Report Number: 3005168196-2019-01928
• Device Sequence Number: 2054711
• Product Code: HCG
• UDI-Device Identifier: 00814548015385
• UDI-Public: 00814548015385
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2019
• 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: 10/14/2023
• Device Catalogue Number: 400SMTXSFT0406
• Device Lot Number: F86443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 86
• Date Report Sent to FDA: 01/01/2005