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

Catalog Number	400SMTSTD1260
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 using penumbra smart coils (smart coils).During the procedure, while using a smart coil with a non-penumbra microcatheter, the smart coil unintentionally detached.Therefore, the physician used a guidewire to push the detached coil into the aneurysm.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the smart coil pusher assembly was fractured approximately 32.0 cm from its proximal end and kinked in close proximity on either end of the fracture.The proximal constraint sphere was not present inside the distal detachment tip (ddt).The pet lock was intact on the proximal end of the pusher assembly.Conclusions: evaluation of the returned smart coil pusher assembly revealed it was fractured, kinked, and its embolization coil was detached.These damages were likely a result of forcefully advancing the device against resistance.If the pusher assembly fractures it will likely allow the pull wire to retract from the ddt effectively detaching the embolization coil.The embolization coil, introducer sheath, and non-penumbra microcatheter were not returned with the subject smart coil.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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7129555
• Report Number: 3005168196-2017-02231
• Device Sequence Number: 977824
• Product Code: HCG
• UDI-Device Identifier: 00814548014449
• UDI-Public: 00814548014449
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2017

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: 04/23/2022
• Device Catalogue Number: 400SMTSTD1260
• Device Lot Number: F75832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/21/2017
• Supplement Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR