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

Model Number	400SMTSTD0715
Medical Device Problem Codes	Difficult or Delayed Separation (4044); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2022-00080.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a basilar aneurysm using penumbra smart coils (smart coils), penumbra smart coil handles (handles), and a non-penumbra microcatheter.During the procedure, the physician advanced a smart coil through the microcatheter to the target vessel and attempted to detach it using the handle; however, the smart coil failed to detach.Therefore, the physician attempted to detach the smart coil with a new second handle; however, the smart coil failed to detach.The physician also attempted to manually detach the smart coil but was unsuccessful.Therefore, the smart coil was removed.Next, the physician successfully implanted two new smart coils using the second handle and the microcatheter.Subsequently, the physician advanced a new smart coil through the microcatheter to the target vessel and attempted to detach it using the second handle; however, the smart coil failed to detach.Therefore, the physician attempted to detach the smart coil with a new third handle; however, the smart coil failed to detach.The physician also attempted to manually detach the smart coil but was unsuccessful.The physician then removed the pusher assembly of the smart coil and realized that the embolization coil was not attached to the pusher assembly.Therefore, the physician removed the microcatheter and flushed the detached smart coil out of the microcatheter.Subsequently, the physician reinserted the microcatheter and successfully implanted a new smart coil in the target vessel using the third handle.The physician then advanced another smart coil into the target vessel then used the third handle to detach the smart coil; however, the smart coil failed to detach.The physician also attempted to manually detach the smart coil but was unsuccessful.The physician then removed the pusher assembly of the smart coil and realized that the embolization coil was not attached to the pusher assembly.Therefore, the physician removed the and flushed the detached smart coil out of the microcatheter.Microcatheter the procedure was completed using a new smart coil, a new fourth handle, and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the second returned smart coil confirmed that the embolization coil was detached.Evaluation revealed that the pet lock was separated on the proximal end of the pusher assembly, the pull wire was retracted out of the ddt, and the embolization coil was detached from its pusher assembly.This indicates a successful detachment attempt.The root cause of the reported complaint could not be determined.Further evaluation revealed kinks in the pusher assembly.This damage was incidental to the reported complaint and the root cause could not be determined.Evaluation of the third returned smart coil confirmed that the embolization coil was detached.Evaluation revealed that the pet lock was separated on the proximal end of the pusher assembly, the pull wire was retracted out of the ddt, and the embolization coil was detached from its pusher assembly.This indicates a successful detachment attempt.The root cause of the reported complaint could not be determined.Further evaluation revealed multiple kinks in the pusher assembly throughout its length.This damage was incidental to the reported complaint and the root cause could not be determined.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 fr report number: 3005168196-2022-00080.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 13604344
• Report Number: 3005168196-2022-00079
• Device Sequence Number: 14917166
• Product Code: HCG
• UDI-Device Identifier: 00814548014487
• UDI-Public: 00814548014487
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023
• 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: 05/05/2016
• Device Model Number: 400SMTSTD0715
• Device Catalogue Number: 400SMTSTD0715
• Device Lot Number: F106030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• 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: 01/26/2022
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• 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
• Patient Age: 78 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005