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

Catalog Number	400SMTSFT0515
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
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 coil), a smart coil detachment handle (handle), a benchmark 6f 071 delivery catheter (benchmark) and two non-penumbra microcatheters.During the procedure, the physician advanced a smart coil into the target vessel using a microcatheter, then attempted to detach it using the handle.It was reported that the pusher assembly of the smart coil had suggested that the smart coil was detached into the target vessel.However, while removing the pusher assembly and catheter, the physician noticed under fluoroscopy that the smart coil had unintentionally detached outside of the target vessel.The physician then attempted to push the smart coil into the target vessel using the microcatheter; however, the microcatheter kicked out of the target vessel.Subsequently, the smart coil moved a few centimeters outside of the target vessel.The microcatheter was then removed, and the physician successfully removed the smart coil using the non-penumbra catheter and a snare device.The physician then advanced another smart coil into the target vessel using the microcatheter, then attempted to detach it using the handle.However, the smart coil failed to detach.After a few failed attempts to detach the smart coil, the smart coil was removed.The procedure was completed using a non-penumbra microcatheter, a non-penumbra catheter, and four non-penumbra coils.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.
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revealed that the pet lock was separated on the proximal end of the pusher assembly and the pull wire was retracted.This typically occurs during a detachment attempt via actuation of the detachment handle.Based on the returned condition, the root cause of the reported complaint could not be determined.Further evaluation revealed kinks along the length of the pusher assembly and offset coil winds on the embolization coil.This damage was incidental to the reported complaint.The pusher assembly kinks may have occurred during packaging for return to penumbra.Penumbra devices 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: 17178112
• Report Number: 3005168196-2023-00292
• Device Sequence Number: 6333505
• Product Code: HCG
• UDI-Device Identifier: 00814548014944
• UDI-Public: 814548014944
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (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): 08/01/2023
• 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: 06/17/2024
• Device Catalogue Number: 400SMTSFT0515
• Device Lot Number: F91078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2023
• 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: 05/29/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2019
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005