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

Catalog Number	400SMTXSFT0103
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, a smart coil would not advance at all within its introducer sheath; therefore, it was removed.The procedure was completed using a new smart coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked at approximately 136.0 cm and 138.0 cm from the proximal end.The pusher assembly was fractured at approximately 137.0 cm from the proximal end.The pusher assembly mid-joint was retracted within the introducer sheath friction lock.The pull wire was retracted from the distal detachment tip (ddt) and the embolization coil was detached from the pusher assembly.Conclusions: evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted into the introducer sheath friction lock.If pusher assembly the mid-joint is retracted inside the introducer sheath friction lock, resistance will likely be experienced while advancing the device.Further investigation revealed pusher assembly kinks, a fractured pusher assembly, the pull wire was retracted from the ddt and the embolization coil was detached within its introducer sheath.If the smart coil is forcefully advanced against resistance, damage such as a kinked and fractured pusher assembly may occur.If the pusher assembly fractures, the pull wire will likely retract out of the ddt and the embolization coil will detach.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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9492688
• Report Number: 3005168196-2019-02376
• Device Sequence Number: 2981293
• Product Code: HCG
• UDI-Device Identifier: 00814548015194
• UDI-Public: 00814548015194
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 11/26/2019
• 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: 11/20/2022
• Device Catalogue Number: 400SMTXSFT0103
• Device Lot Number: F80647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 63
• Date Report Sent to FDA: 01/01/2005