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

Model Number	400SMTSFT3H06
Medical Device Problem Codes	Unraveled Material (1664); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
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 in the internal carotid artery (ica) using a penumbra smart coil (smart coil), a penumbra smart coil detachment handle (handle), non-penumbra catheter, non-penumbra microcatheter, guidewire, and a non-penumbra stent.During the procedure, the physician advanced a smart coil as the first coil into the vessel and used the handle to detach it; however, the smart coil failed to detach after several attempts.The physician then broke the black alignment zone on the pusher assembly of the smart coil and pulled the inner wire in attempt to manually detach the smart coil.However, the coil did not detach.Consequently, during the attempts, the smart coil became unraveled.Therefore, the physician used a goose neck snare to retrieve the smart coil and removed the microcatheter all together.The procedure was completed using other coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil embolization coil revealed that the proximal constraint sphere was intact at the proximal end of the embolization coil.This indicates that the embolization coil was not unraveled and was detached as intended.The smart coil pusher assembly was not returned for evaluation; therefore, the reported smart coil failure to detach during the procedure could not be determined.The reported smart coil unraveled during the procedure was unable to be confirmed.Further evaluation of the device revealed offset coil winds along the length of the embolization coil.This damage was likely a result of snaring to retrieve the embolization coil during the procedure.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported complaint due to the return condition.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.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: 11604025
• Report Number: 3005168196-2021-00658
• Device Sequence Number: 3621403
• Product Code: HCG
• UDI-Device Identifier: 00814548017006
• UDI-Public: 00814548017006
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2021
• 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: 02/20/2022
• Device Model Number: 400SMTSFT3H06
• Device Catalogue Number: 400SMTSFT3H06
• Device Lot Number: F74542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Date Report Sent to FDA: 01/01/2005