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

Catalog Number	400SMTSFT0506
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2019
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 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: 3005168196-2019-02192.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle cerebral artery (mca) using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).During the procedure, the physician advanced a non-microcatheter between two stent devices into the target vessel and placed a non-penumbra coil.Next, the physician advanced a smart coil into target vessel and detached it using the handle.However, when the pusher assembly of the smart coil was pulled, the physician noticed the smart coil was retracted a few centimeters with the pusher assembly.Therefore, the smart coil was re-advanced into the target vessel and an attempt was made to detach it by pulling the trigger of the handle.However, after pulling the pusher assembly of the smart coil, the smart coil was retracted again and detached a few centimeters into the microcatheter.Therefore, the physician used the pusher assembly to push the remaining smart coil into target vessel.It was also reported that resistance was met while attempting to advance three other coils through the microcatheter and the coils would not advance.Therefore, the microcatheter was removed and upon flushing saline through the microcatheter on a pad, two ¿foreign¿ materials were found.The procedure was completed using other coils with a new microcatheter.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: 9371609
• Report Number: 3005168196-2019-02191
• Device Sequence Number: 11318813
• Product Code: HCG
• UDI-Device Identifier: 00814548015149
• UDI-Public: 00814548015149
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/29/2019
• 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
• Device Expiration Date: 04/08/2023
• Device Catalogue Number: 400SMTSFT0506
• Device Lot Number: F82749
• 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: 10/29/2019
• Initial Report FDA Received Date: 11/25/2019
• 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