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

Model Number	400SMTHXSFT1H02
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, smart coils were successfully implanted in the target location.While attempting to place the next smart coil, a penumbra smart coil detachment handle (handle) was unable to detach it after several attempts.The physician then attempted to manually detach the smart coil without success.Therefore, the smart coil was retracted for removal.When the smart coil was withdrawn into the microcatheter, it detached.Subsequently, the microcatheter containing the detached smart coil was removed from the patient and the smart coil was removed from the microcatheter.The procedure was completed using another smart coil, the same handle, and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil pusher assembly revealed that the pet lock was broken, the pull wire was retracted out of the ddt, and the embolization coil was detached from its pusher assembly.This indicated that the smart coil was detached as intended.The detached embolization coil and the handle used in the procedure were not returned for evaluation; therefore, the root cause of the reported detachment issue could not be determined.Further evaluation of the returned smart coil pusher assembly revealed a proximal kink.This damage was likely occurred due to the manual detachment attempted during the procedure.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.H3 other text: placeholder.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11635996
• Report Number: 3005168196-2021-00711
• Device Sequence Number: 17030779
• Product Code: HCG
• UDI-Device Identifier: 00814548015651
• UDI-Public: 00814548015651
• Combination Product (Y/N): Y
• Initial Reporter State: ME
• 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,Followup
• Report Date (Section B): 03/12/2021
• 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: 04/27/2025
• Device Model Number: 400SMTHXSFT1H02
• Device Catalogue Number: 400SMTHXSFT1H02
• Device Lot Number: F97576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 05/04/2021
• 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