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

Catalog Number	400SMTXSFT1H02
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was intact with the pusher assembly distal detachment tip (ddt) and was undamaged.The smart coil was able to advance through its introducer sheath and a demonstration microcatheter without resistance.Conclusions: evaluation of the returned smart coil revealed a functional device.The device was undamaged.During functional testing the smart coil was able to advance through its introducer sheath and a demonstration microcatheter without resistance.The complaint reported that a white foreign substance was found and cleaned from the returned smart coil.It is likely that this foreign substance contributed to the reported resistance experienced during the procedure.The root cause of this substance was unable to be determined.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 successfully deployed four coils into the target vessel using a non-penumbra microcatheter.Upon advancement of the fifth smart coil, the physician felt resistance and decided to remove the smart coil and introducer sheath together from the microcatheter.The procedure was completed using two other coils and the same microcatheter.There was no report of an adverse effect to the patient.It should also be noted that, upon inspection of the smart coil and pusher assembly after the procedure, a penumbra employee found an unknown white scaly substance on the pusher wire.The penumbra employee then cleaned the pusher wire and was able to advance the smart coil with little resistance.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8238355
• Report Number: 3005168196-2019-00049
• Device Sequence Number: 1558012
• Product Code: HCG
• UDI-Device Identifier: 00814548015224
• UDI-Public: 00814548015224
• Combination Product (Y/N): Y
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2018
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 08/08/2023
• Device Catalogue Number: 400SMTXSFT1H02
• Device Lot Number: F85166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 56
• Date Report Sent to FDA: 01/01/2005