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

Model Number	400SMTSFT0615
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
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 smart coil detachment handle (handle).During the procedure, the physician successfully detached smart coils using the handle.While attempting to detach the next smart coil, the coil would not detach after approximately five attempts were made to detach it.The physician made an attempt to detach the smart coil manually without success.Therefore, the smart coil was removed.The procedure was completed using additional smart coils and the same handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil confirmed the embolization coil was still intact with the pusher assembly.The pet lock was separated, the pull wire was not present on the proximal end of the pusher assembly, and the pull wire was still within the pusher assembly ddt alignment feature.This indicates that the pull wire may have become fractured, possibly due to the multiple detachment attempts made using the handle and manual detachment during the procedure.Further evaluation revealed pusher assembly kinks and offset coil winds along the embolization coil.This damage may be incidental to the reported complaint and may have occurred during packaging for return to penumbra.The root cause of the reported event could not be determined.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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of smart coil detachment issue 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: 11949765
• Report Number: 3005168196-2021-01265
• Device Sequence Number: 1061253
• Product Code: HCG
• UDI-Device Identifier: 00814548014975
• UDI-Public: 00814548014975
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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): 07/09/2021
• 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: 01/31/2026
• Device Model Number: 400SMTSFT0615
• Device Catalogue Number: 400SMTSFT0615
• Device Lot Number: F103585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 07/09/2021
• 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