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

Catalog Number	400SMTHXSFT0308
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	07/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle meningeal artery (mma) using penumbra smart coils (smart coil), smart coil detachment handles (handle), a non-penumbra microcatheter, and a guidewire.During the procedure, the physician advanced a smart coil using a microcatheter into the target vessel and attempted to detach the smart coil using the handle several times; however, the smart coil failed to detach.Then the physician used a second handle without success.Therefore, the physician decided to remove the smart coil.While retracting, the smart coil unintentionally detached within the microcatheter.The physician then used the detached smart coil''s pusher wire to advance the smart coil out of the microcatheter and into the target vessel.Next, the physician advanced a second smart coil into the target vessel and attempted to detach the smart coil using the second handle; however, the smart coil would not detach.Therefore, the smart coil was removed.The procedure was completed using a non-penumbra coil and the same microcatheter.There was no report of an adverse effect to the patient.
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.H3 other text : placeholder.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report: 3005168196-2023-00354.Section e.Box 1.Title; section h.Box 6.Evaluation codes: device code 1.Evaluation of the returned smart coil confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the pet lock was separated, the pull wire was retracted out of the pusher assembly distal tip and the embolization coil was detached.This typically occurs during a successful detachment.Based on the reported event, the root cause of the detachment issue during the procedure could not be determined.Further evaluation revealed pusher assembly bends throughout its length.This damage was likely incidental to the complaint and may have occurred during packaging for return to penumbra.Penumbra products 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 complaint due to the return condition.

• 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: 17402770
• Report Number: 3005168196-2023-00354
• Device Sequence Number: 7493437
• Product Code: HCG
• UDI-Device Identifier: 00814548015798
• UDI-Public: 814548015798
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2023
• 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 Catalogue Number: 400SMTHXSFT0308
• Device Lot Number: F113599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2023
• 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: 07/05/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2022
• 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: 89 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005