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

Model Number	400SMTXSFT0103
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	09/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-02362.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra smart coils (smart coils), non-penumbra coils, and a non-penumbra microcatheter.It was noted that the patient¿s anatomy was mildly tortuous.During the procedure, the physician placed three smart coils and seven other coils in the target vessel using the microcatheter.Subsequently, the physician experienced resistance while advancing the next two smart coils in the hub of the microcatheter.Therefore, the smart coils was removed.The procedure was completed using additional smart coils, another coil, and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned first smart coil revealed offset coil winds throughout the length of its embolization coil.This damage was likely a result of forceful advancement the device against resistance.If the introducer sheath is not properly aligned within the hub of the microcatheter prior to advancement, the embolization coil may take shape within the hub and resistance may encounter during advancement.Forceful advancement against this resistance may contributed to the offset coil winds.During functional testing, the smart coil was unable to advance through the hub of a demonstration microcatheter due to the offset coil winds on the embolization coil.Further evaluation revealed pusher assembly kinks.These kinks were likely incidental to the complaint and may have occurred during packaging for return to penumbra.Evaluation of the returned second smart coil revealed offset coil winds along the length of its embolization coil.This damage was likely a result of forceful advancement the device against resistance.If the introducer sheath is not properly aligned within the hub of the microcatheter prior to advancement, the embolization coil may take shape within the hub and resistance may encounter during advancement.Forceful advancement against this resistance may contributed to the offset coil winds.During functional testing, the smart coil was unable to advance through the hub of a demonstration microcatheter due to the offset coil winds on the embolization coil.Further evaluation revealed that the pet lock was separated.This damage was likely incidental to the complaint.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.This report is associated with mfr report number: 3005168196-2021-02362.H3 other text: placeholder.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• MDR Report Key: 12686029
• Report Number: 3005168196-2021-02363
• Device Sequence Number: 3856298
• Product Code: HCG
• UDI-Device Identifier: 00814548015194
• UDI-Public: 00814548015194
• 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): 11/03/2021
• 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: 11/07/2021
• Device Model Number: 400SMTXSFT0103
• Device Catalogue Number: 400SMTXSFT0103
• Device Lot Number: F72693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 11/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005