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

Model Number	400SMTSTD0408
Medical Device Problem Codes	Stretched (1601); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The smart coil was implanted in the patient; however, the pusher assembly 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: 3005168196-2021-02308.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (aca) using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), a non-penumbra microcatheter, and a guidewire.During the procedure, the physician advanced a smart coil into the target location using the microcatheter and attempted to detach it using the handle; however, the smart coil failed to detach.The physician then made two other attempts, but the smart coil would not detach.Next, the physician attempted to manually detach the smart coil, but it was unsuccessful.Afterwards, the physician made three attempts to detach the smart coil using medical pliers, but the smart coil did not detach.It was reported that the physician noticed that the pusher assembly kept stretching but the smart coil did not detach.The physician then decided to remove the smart coil.Upon retracting approximately three centimeters of the smart coil into the microcatheter, the smart coil detached.Subsequently, the physician removed the pusher assembly of the smart coil and then used the guidewire to successfully push the detached smart coil into the target location.The procedure was completed using three other coils, the same microcatheter, and the same guidewire.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed, that the pet lock was separated.And the pull wire was retracted out of the pusher assembly ddt.This typically occurs, when a detachment attempt is made using a handle.Further evaluation revealed, that the pusher assembly was returned twisted together.This damage was likely incidental to the reported complaint.Due to the return damage, the cause of the detachment issue, during the procedure could not be determined.Evaluation of the returned handle revealed, and undamaged functional device.The nose cone funnel was measured and was within specification.The handle was tested on a handle test fixture and performed within specification.The handle was also, used to detach a demonstration smart coil without an issue.The root cause of the detachment issue, during the procedure could not be determined.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are 100% visually inspected and functionally testing, during incoming quality inspection.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: 3005168196-2021-02308.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12643845
• Report Number: 3005168196-2021-02307
• Device Sequence Number: 19176427
• Product Code: HCG
• UDI-Device Identifier: 00814548014593
• UDI-Public: 00814548014593
• Combination Product (Y/N): Y
• Initial Reporter Country: PL
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2021
• 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: 08/28/2024
• Device Model Number: 400SMTSTD0408
• Device Catalogue Number: 400SMTSTD0408
• Device Lot Number: F92831
• Was Device Available for Evaluation?: Yes
• 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: 09/21/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 10/16/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2019
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Date Report Sent to FDA: 01/01/2005