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

Catalog Number	400SMTXSFT2H08
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle cerebral artery (mca) using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle) and a non-penumbra microcatheter.During the procedure, the physician advanced a smart coil in the target vessel using the microcatheter and attempted to detach it using a handle; however, the smart coil failed to detach.The physician then attempted to detach the smart coil using a new handle, but the smart coil would still not detach.Next, the physician attempted to manually detach the smart coil but was unsuccessful.Therefore, the physician decided to remove the smart coil.Upon retraction, the smart coil unintentionally detached with the majority of the smart coil in the aneurysm.Subsequently, the physician used a guidewire to successfully push the remaining part of the detached smart coil into the aneurysm.Afterwards, the following smart coil, would not advance at all from its initial position within its introducer sheath; therefore, the smart coil was removed.The procedure was completed using other coils and the same microcatheter.There was no report of an adverse effect to the patient.
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.
Additional Manufacturer Narrative
Evaluation of the returned smart coil confirmed that the embolization coil was detached from its pusher assembly.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revealed that the pet lock was separated on the proximal end of the pusher assembly, and the pull wire was retracted out of the distal detachment tip (ddt).This typically occurs during a successful detachment.Based on the returned condition, the root cause of the reported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 ovalization on the introducer sheath and kinks near the proximal end of 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.

• 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: 15671758
• Report Number: 3005168196-2022-00495
• Device Sequence Number: 6368680
• Product Code: HCG
• UDI-Device Identifier: 00814548015576
• UDI-Public: 814548015576
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2022
• 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 Expiration Date: 05/25/2026
• Device Catalogue Number: 400SMTXSFT2H08
• Device Lot Number: F106613
• 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: 09/29/2022
• Supplement Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2021
• 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: 20 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Date Report Sent to FDA: 01/01/2005