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

Catalog Number	400SMTHXSFT2H08
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	05/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the spinal artery using penumbra smart coils (smart coil), a smart coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician advanced a smart coil into the target vessel using the microcatheter and attempted to detach it using the handle.However, the smart coil failed to detach.The physician then was able to detach the smart coil after making another attempt.Next, the physician advanced another smart coil into the target vessel and attempted to detach it using the handle; however, the smart coil failed to detach.The physician also attempted to manually detach the smart coil, but the smart coil would still not detach.The physician then decided to remove the smart coil.However, while retracting the smart coil, it unintentionally detached.Therefore, the physician implanted approximately four to five non-penumbra coils on top of the detached smart coil to keep it in place.The physician then advanced a third smart coil into the target vessel and attempted to detach it using the handle; however, the smart coil failed to detach.The physician also attempted to manually detach the smart coil, but the smart coil would still not detach.Therefore, the smart coil was removed.The procedure was completed using ten non-penumbra coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 3005168196-2022-00293.1.Section h.Box 6.Device code 1.Evaluation of the 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revealed that the pet lock was separated on the proximal end of the pusher assembly, and the pull wire was retracted out of the ddt.This type of damage typically occurs during a successful detachment.Based on the returned condition, the root cause of the reported complaint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.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.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 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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 14713785
• Report Number: 3005168196-2022-00293
• Device Sequence Number: 2265077
• Product Code: HCG
• UDI-Device Identifier: 00814548016016
• UDI-Public: 814548016016
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022
• 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 Catalogue Number: 400SMTHXSFT2H08
• Device Lot Number: F110922
• 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: 05/23/2022
• Supplement Date Received by Manufacturer: 07/04/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2021
• 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: 61 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005