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

Catalog Number	400SMTSFT3H06
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2018
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: 3005168196-2018-01042.The hospital discarded the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils) and two penumbra smart coil detachment handles (handles).During the procedure, the physician successfully placed two coils using a non-penumbra microcatheter.The physician then advanced and attempted to detach a smart coil in the target location, however the smart coil did not detach, despite three attempts with the handle.The physician, therefore, attempted to detach the smart coil using a new handle, however the smart coil still did not detach.The smart coil was therefore removed, and the procedure was completed using two other coils and the same 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: 7538792
• Report Number: 3005168196-2018-01043
• Device Sequence Number: 2412562
• Product Code: HCG
• UDI-Device Identifier: 00814548017006
• UDI-Public: 00814548017006
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2018

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: 12/04/2021
• Device Catalogue Number: 400SMTSFT3H06
• Device Lot Number: F73015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1