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

Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 3005168196-2019-00720; 3005168196-2019-00721; 3005168196-2019-00722; 3005168196-2019-00724; 3005168196-2019-00725.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the vertebral artery (va) using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).During the procedure, the physician advanced a smart coil into the target vessel and attempted to detach it using the handle.It was reported that the handle was depressed several times before the smart coil detached into the vessel.The same issue occurred again with four additional smart coils.The procedure was completed successfully using additional smart coils and the same handle.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8524883
• Report Number: 3005168196-2019-00723
• Device Sequence Number: 2689564
• Product Code: HCG
• UDI-Device Identifier: 00814548015750
• UDI-Public: 00814548015750
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/18/2019
• 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
• Was Device Available for Evaluation?: No
• 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: 03/18/2019
• Initial Report FDA Received Date: 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005