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

Catalog Number	400SMTSTD0515
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2017
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: 3005168196-2017-01202.The device was implanted into the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure for a vessel sacrifice in the anterior cerebral artery-anterior communicating artery (aca-acom) using penumbra smart coils (smart coil) and a penumbra smart coil detachment handle (handle).During the procedure, the physician deployed an initial smart coil into the target vessel and made one attempt to detach it using the handle but was unsuccessful.A second attempt was made to detach the coil using the same handle and the coil detached successfully.The procedure was then completed using three additional smart coils and the same handle.There was no report of an adverse effect to the patient.The patient was discharged on (b)(6) 2017.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6723714
• Report Number: 3005168196-2017-01201
• Device Sequence Number: 10809827
• Product Code: HCG
• UDI-Device Identifier: 00814548014647
• UDI-Public: 00814548014647
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2017

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: Physician
• Device Expiration Date: 10/05/2021
• Device Catalogue Number: 400SMTSTD0515
• Device Lot Number: F71965
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2017
• Initial Report FDA Received Date: 07/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR