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

Model Number	400SMTHXSFT0204
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed offset coil winds along the length of its embolization coil.If the device is forcefully advance against resistance, damage such as offset coil winds may occur.During functional testing, the smart coil was unable to advance through its introducer sheath due to the offset coil winds on the embolization coil, and functional testing could not be continued.The root cause of the resistance experienced during the procedure could not be determined.Further evaluation of the device revealed pusher assembly kinks.These kinks were likely incidental to the complaint and may have occurred during packaging for returned to penumbra.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 using penumbra smart coils (smart coils) and a microcatheter.During the procedure, four smart coils were successfully implanted in the target location.While attempting to introduce the fifth smart coil to the microcatheter, the coil would not advance past its initial position within its introducer sheath.Therefore, the smart coil was removed and set aside.Next, another smart coil was successfully implanted in the target location.When the physician made a second attempt to advance the same smart coil past its initial position within its introducer sheath, the coil advanced into the microcatheter and subsequently became stuck.Therefore, the smart coil was removed and was no longer used in the procedure.The procedure was completed using another smart coil 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: 11489682
• Report Number: 3005168196-2021-00502
• Device Sequence Number: 5257518
• Product Code: HCG
• UDI-Device Identifier: 00814548015712
• UDI-Public: 00814548015712
• 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): 02/17/2021
• 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: 11/03/2025
• Device Model Number: 400SMTHXSFT0204
• Device Catalogue Number: 400SMTHXSFT0204
• Device Lot Number: F101700
• 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: 02/17/2021
• Initial Report FDA Received Date: 03/15/2021
• 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