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

Model Number	SCH1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
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.This report is associated with mfr report number: 3005168196-2021-02661.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the vertebral artery using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), a non-penumbra microcatheter, and a non-penumbra catheter.During the procedure, the physician placed and detached four smart coils using the handle and two non-penumbra coils in the target vessel.After advancing another smart coil into the target location, the handle failed to detach the coil after several attempts.Therefore, the smart coil and the handle were removed.The procedure was completed using three other coils, the same microcatheter and the same catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil could not confirm the reported complaint.Evaluation revealed that the pet lock was separated.This damage likely occurred due to coil detachment attempted during the procedure.Evaluation also revealed that the pusher assembly was fractured and ovalized, the pull wire was retracted from the pusher assembly ddt, the embolization coil was detached from the pusher assembly and had offset coil winds.This damage was incidental to the reported complaint.Based on the returned condition, the root cause of the reported complaint could not be determined.Evaluation of the returned handle could not confirm the reported complaint.Evaluation revealed that the handle was functional and undamaged.During functional testing, the handle was tested with a handle test fixture and performed within specification.The handle was able to detach a demonstration smart coil without issue.Penumbra coils and handles 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.This report is associated with mfr report number: 1.3005168196-2021-02661.

• Brand Name: PENUMBRA SMART COIL DETACHMENT HANDLE
• 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: 12857582
• Report Number: 3005168196-2021-02662
• Device Sequence Number: 14662678
• Product Code: HCG
• UDI-Device Identifier: 00814548016139
• UDI-Public: 00814548016139
• 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): 12/06/2021
• 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: 02/15/2026
• Device Model Number: SCH1
• Device Catalogue Number: SCH1
• Device Lot Number: F103915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• 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: 10/26/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2021
• 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: 86 YR
• Patient Sex: Male
• Patient Weight: 52 KG
• Date Report Sent to FDA: 01/01/2005