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

Model Number	400SMTSTD1045
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed offset coil winds on the embolization coil and a kink in the pusher assembly.If the smart coil is forcefully advanced against resistance, damage such as this may occur.During the functional test, the smart coil was advanced out of its introducer sheath without an issue.Resistance was then encountered while attempting to advance the smart coil through a demonstration microcatheter due to a kink in the pusher assembly, and the smart coil could not be advanced any further.Further evaluation revealed additional kinks on the pusher assembly.This damage is likely incidental to the reported complaint and the root cause could not be determined.Penumbra coils are visually 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 internal iliac artery (iia) using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, the physician implanted three smart coils into the target location before removing the microcatheter and flushing it on the back table.While advancing the next smart coil through the middle of the microcatheter, the physician encountered resistance.Therefore, the smart coil and the microcatheter were removed and flushed on the back table.Next, the same smart coil was re-advanced through the microcatheter and the same issue occurred; therefore, the smart coil was removed and no longer used in the procedure.The procedure was completed using three other smart coils and the same microcatheter.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: 11570850
• Report Number: 3005168196-2021-00586
• Device Sequence Number: 3598673
• Product Code: HCG
• UDI-Device Identifier: 00814548014401
• UDI-Public: 00814548014401
• 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
• Report Date (Section B): 02/24/2021
• 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: 08/20/2022
• Device Model Number: 400SMTSTD1045
• Device Catalogue Number: 400SMTSTD1045
• Device Lot Number: F78753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• 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: 02/24/2021
• Initial Report FDA Received Date: 03/25/2021
• 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