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

Catalog Number	400SMTHXSFT0306
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	06/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar artery using penumbra smart coils (smart coils), penumbra smart coil detachment handles (handles), and a non-penumbra microcatheter.It should be noted that the patient's anatomy was tortuous in the v3 towards the v4.During the procedure, the physician successfully implanted twelve coils (unknown).After advancing a smart coil into the target vessel, the handle was used to detach the coil; however, the coil did not detach after five attempts were made.Therefore, the smart coil was removed.Next, another smart coil was successfully detached in the target location using the same handle.After advancing the next smart coil into the target location, the handle was used to detach the coil; however, the coil did not detach after multiple attempts were made.It was reported that when the handle slider was pulled, the physician felt the smart coil was being pulled backwards.Therefore, the handle was removed.A new handle was used to detach the same smart coil; however, the coil did not detach.It was reported that when the handle slider was pulled, the same issue occurred.Therefore, the handle was removed.Upon removal of the smart coil, resistance was encountered and the coil unintentionally detached inside the microcatheter approximately four centimeters from the distal end.The guidewire (unknown) was used to implant the detached smart coil.The procedure was completed using two non-penumbra coils 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.
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 second returned smart coil confirmed that the embolization coil was detached.Evaluation revealed that the pet lock was separated, the pull wire was retracted from the ddt and the embolization coil was detached.This indicated that the embolization coil was detached properly.The detached embolization coil was not returned for evaluation.Due to the returned condition, the root cause of the detachment issue could not be determined.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.

• 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: 14860572
• Report Number: 3005168196-2022-00311
• Device Sequence Number: 17533457
• Product Code: HCG
• UDI-Device Identifier: 00814548015781
• UDI-Public: 814548015781
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022
• 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: 08/27/2025
• Device Catalogue Number: 400SMTHXSFT0306
• Device Lot Number: F99865
• 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: 06/09/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2020
• 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 Sex: Male
• Date Report Sent to FDA: 01/01/2005