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

Catalog Number	400SMTHXSFT0206
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 basilar artery using penumbra smart coils (smart coil), a penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician placed and detached smart coils in the target vessel using the handle.Next, the physician advanced another smart coil into the target vessel and attempted to detach it using a handle; however, the smart coil failed to detach.It was also reported that the physician attempted to manually detach the smart coil; however, the coil would not detach.Therefore, the smart coil and handle were removed.The physician then advanced and detached new smart coils in the vessel using a new handle.Subsequently, the physician advanced another smart coil into vessel and attempted to detach it using the second handle but, the smart coil failed to detach.Therefore, the physician decided to remove the smart coil; however, while retracting, the smart coil had unintentionally detached inside the microcatheter.The microcatheter containing the detached smart coil was then removed.The procedure was completed using non-penumbra coils and a new microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the second returned smart coil confirmed the embolization coil was detached from its pusher assembly inside a non-penumbra microcatheter.Further evaluation revealed that the pet lock was separated, and the pusher assembly had kinks along its length and was unable to be removed from the non-penumbra microcatheter.The pet lock separation likely occurred during the detachment attempt.No damage was observed on the non-penumbra microcatheter; therefore, the root cause of the resistance while attempting to retract the pusher assembly could not be determined.Due to the return condition, the root cause of the reported complaint could not be determined.Penumbra coils are 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: 14322118
• Report Number: 3005168196-2022-00204
• Device Sequence Number: 17289663
• Product Code: HCG
• UDI-Device Identifier: 00814548015972
• UDI-Public: 814548015972
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2022
• 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: 400SMTHXSFT0206
• Device Lot Number: F106599
• 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: 04/12/2022
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 05/27/2022
• 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: 72 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005