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

Catalog Number	400SMTXSFT0104
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the embolization coil was intact with the penumbra smart coils (smart coils) pusher assembly, was inside the introducer sheath friction lock, and had offset coil winds.The pusher assembly was kinked approximately 135.0 cm from the proximal end.Conclusion: evaluation of the returned device revealed the smart coil embolization coil had offset coil winds and the pusher assembly was kinked.This damage likely occurred due to forceful advancement of the smart coil against resistance.Resistance may be experienced if the introducer sheath is not properly aligned within the hub of the microcatheter prior to advancement.Further evaluation revealed the embolization coil could not track smoothly when attempts were made to advance the smart coil, and the embolization coil could not advance out of the introducer sheath when re-sheathed due to the offset coil winds.Penumbra coils and catheters 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 to treat a posterior communicating artery (pcom) aneurysm using penumbra smart coils (smart coils).During the procedure, the physician successfully placed multiple smart coils using a non-penumbra microcatheter.The physician then was unable to advance a smart coil out of its introducer sheath and into the 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 it was still unable to be advanced.The procedure was then completed using the same microcatheter and a new smart coil.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: 7043180
• Report Number: 3005168196-2017-02067
• Device Sequence Number: 16653476
• Product Code: HCG
• UDI-Device Identifier: 00814548015507
• UDI-Public: 00814548015507
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2017

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: 05/23/2022
• Device Catalogue Number: 400SMTXSFT0104
• Device Lot Number: F77295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR