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

Catalog Number	400SMTXSFT0204
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right posterior communicating artery (pcom) using penumbra smart coils (smart coil), a penumbra smart coil detachment handle (handle), non-penumbra coil, and a non-penumbra microcatheter.During the procedure, the physician placed and detached four smart coils in the target location using the handle.Subsequently, a non-penumbra coil was then placed after the four smart coils using the microcatheter.Next, the physician advanced another smart coil into the vessel and attempted to detach it using a handle; however, the smart coil failed to detach.The physician attempted to manually detach the smart coil as well as using a new handle to detach the coil; however, the attempts were unsuccessful.Therefore, the physician decided to remove the smart coil.However, while retracting the coil, the physician experienced resistance and noticed the smart coil had unintentionally detached.It was also reported that half of the detached smart coil was inside aneurysm and the other half of the coil was outside aneurysm.The physician, therefore, used a gooseneck snare to remove the detached smart coil.The procedure was completed using four additional smart coils, a non-penumbra coil, and the same handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Section h box 6 (4316): the investigation findings do not lead to a clear conclusion about the root cause of the reported complaint due to the return condition.Evaluation of the returned smart coil confirmed that the embolization coil was detached from the pusher assembly.Evaluation also revealed that the pet lock was separated, the pull wire was retracted on the proximal end of the pusher assembly.This indicates a successful detachment attempt.If the pull wire is retracted, the embolization coil will likely detach.Based on the returned condition, the root cause of the detachment issue during the procedure could not be determined.The embolization coil was returned inside the non-penumbra catheter and snare device and was unable to be removed from the snare device.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.
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 #02 mfr report: 3005168196-2022-00333.1.Section a.Box 2.Age at time of event.2.Section g.Box 3.Report source 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: 15023651
• Report Number: 3005168196-2022-00333
• Device Sequence Number: 6781812
• Product Code: HCG
• UDI-Device Identifier: 00814548015286
• UDI-Public: 814548015286
• 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
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2022
• 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: 11/15/2025
• Device Catalogue Number: 400SMTXSFT0204
• Device Lot Number: F102012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2022
• 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: 06/22/2022
• Supplement Date Received by Manufacturer: 07/12/2022; 07/11/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 07/21/2022; 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2020
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Date Report Sent to FDA: 01/01/2005