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	09/21/2021
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.This report is associated with mfr report number: 3005168196-2021-02372.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the hepatic artery using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician advanced the first smart coil into the target vessel and made four attempts to detach it using the handle; however, the smart coil failed to detach.It was also reported that the handle did not click.Therefore, the handle and the smart coil were removed.The procedure was completed using a non-penumbra coil and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned handle revealed an undamaged, functional device.The nose cone was removed from the handle and the nose cone funnel was measured with pin gauges to be within specification.The handle was tested on a test fixture and performed within specification.The handle was used to detach a demonstration smart coil without an issue.Further evaluation revealed a scratch mark on the inside of the handle body.This damage is incidental to the complaint and does not affect the handles functionality.Penumbra handles are 100% visually inspected and functionally tested during incoming quality inspection.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: 3005168196-2021-02372.H3 other text : placeholder.

• 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: 12686756
• Report Number: 3005168196-2021-02371
• Device Sequence Number: 4027412
• Product Code: HCG
• UDI-Device Identifier: 00814548016139
• UDI-Public: 00814548016139
• Combination Product (Y/N): Y
• 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): 10/23/2021
• 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: 01/19/2026
• Device Model Number: SCH1
• Device Catalogue Number: SCH1
• Device Lot Number: F103332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• 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: 09/27/2021
• Supplement Date Received by Manufacturer: 10/31/2021
• Initial Report FDA Received Date: 10/23/2021
• Supplement Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2021
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005