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

Catalog Number	400SMTSTD0620
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the smart coil was kinked approximately 11.0 cm and 136.0 cm from its proximal end.Conclusions: evaluation of the returned smart coil revealed the device was able to be advanced through a demonstration microcatheter without issue.Further evaluation revealed minor kinks on the length of the pusher assembly.This was likely a result of attempting to advance the embolization coil against resistance.The root cause of this initial resistance could not be determined as it was not experienced during the device investigation.Penumbra coils are 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using penumbra smart coils (smart coils).During the procedure, the physician was unable to advance a smart coil out of its introducer sheath and into a non-penumbra microcatheter, and therefore the smart coil was removed.The hospital staff attempted to advance the smart coil out of its introducer sheath on the back table, however was still unable to.The procedure was then completed using a new smart coil 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: 7089037
• Report Number: 3005168196-2017-02171
• Device Sequence Number: 11042519
• Product Code: HCG
• UDI-Device Identifier: 00814548014678
• UDI-Public: 00814548014678
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2017

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: 06/12/2022
• Device Catalogue Number: 400SMTSTD0620
• Device Lot Number: F77656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 12/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR