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

Model Number	400SMTSFT0615
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned smart coil confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the pet lock was separated, the pull wire was fractured at the proximal end of the pusher assembly, the pusher assembly had kinks near its proximal end and the pull wire was retracted from its initial position inside the pusher assembly ddt.This damage likely occurred due to the manual coil detachment attempted during the procedure.The embolization coil was detached from the pusher assembly and not returned for evaluation.Based on the returned condition, the root cause of the coil detachment issue could not be determined.Further evaluation of the device revealed additional kinks throughout the length of the pusher assembly.This damage was incidental to the complaint.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The investigation findings do not lead to a clear conclusion about the root cause of the reported initial coil detachment issue.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar artery using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), a non-penumbra catheter, a non-penumbra microcatheter, and a guidewire.During the procedure, the physician successfully implanted four smart coils into the target vessel.Subsequently, the physician advanced the fifth smart coil to the target vessel and attempted to detach the smart coil using a handle; however, the smart coil failed to detach.It was reported that the physician attempted to manually detach the smart coil by bending the proximal end of the pusher assembly and pulling the wire; however, the smart coil still failed to detach.Therefore, the physician attempted to remove the smart coil; however, while retracting the smart coil, it unintentionally detached with approximately three fourths of the smart coil in the microcatheter and approximately one fourth of the smart coil in the target vessel.Therefore, the physician removed the microcatheter with the detached smart coil inside.Next, the physician inserted a new non-penumbra microcatheter into the patient and successfully implanted three new smart coils using the same handle.Subsequently, the physician advanced a new smart coil through the microcatheter to the target vessel and attempted to detach the smart coil using the handle; however, the smart coil failed to detach.Therefore, the smart coil was removed.The procedure was completed using two new smart coils, the same handle, the same non-penumbra catheter, and the same non-penumbra microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:3005168196-2022-00045 1.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: 13476979
• Report Number: 3005168196-2022-00045
• Device Sequence Number: 5247225
• Product Code: HCG
• UDI-Device Identifier: 00814548014975
• UDI-Public: 00814548014975
• 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,Health Professional,Company Representative
• 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: 06/07/2026
• Device Model Number: 400SMTSFT0615
• Device Catalogue Number: 400SMTSFT0615
• Device Lot Number: F106901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• 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: 01/14/2022
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2021
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Date Report Sent to FDA: 01/01/2005