MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL

Catalog Number	400SMTSFT0306
Medical Device Problem Code	Difficult to Advance (2920)
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
Results: the embolization coil was intact with the pusher assembly.The pusher assembly was kinked and bent along its length.There were some offset coil winds on the embolization coil conclusions: evaluation of the first smart coil revealed it was detached and kinked in multiple locations.The embolization coil was not returned so it could not be functionally tested for advancing into a microcatheter.The root cause of the reported failure could not be determined due to the returned condition of the device.Evaluation of the second smart coil revealed a kinked and bent pusher assembly.The embolization coil had a few offset coil winds along its length.During functional testing, the embolization coil was able to be advanced through a demonstration microcatheter.Resistance was experienced when the several kinks were advanced through the demonstration microcatheter.The root cause of the reported inability to advance into a parent device could not be determined.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.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: 3005168196-2018-01034.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, the hospital staff experienced difficulty loading two smart coils into a px slim delivery microcatheter (px slim) and, therefore, the smart coils were removed.The procedure was completed using additional coils.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7543282
• Report Number: 3005168196-2018-01035
• Device Sequence Number: 1871815
• Product Code: HCG
• UDI-Device Identifier: 00814548015040
• UDI-Public: 00814548015040
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date (Section B): 04/26/2018

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: 07/10/2022
• Device Catalogue Number: 400SMTSFT0306
• Device Lot Number: F78090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR