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

Model Number	400SMTHXSFT1H01
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2019
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.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 bent approximately 6.5 and 11.0 cm from the proximal end.The pusher assembly mid-joint was in its initial position within the introducer sheath.The embolization coil was intact with the pusher assembly.Offset coil winds were present along the length of the embolization coil.Conclusions: evaluation of the returned smart coil revealed offset coil winds along the length of the embolization coil.This indicates that the smart coil was likely able to be advanced from its starting position within the introducer sheath; therefore, the reported complaint could not be confirmed.If the introducer sheath is not aligned properly within the hub of a parent device prior to advancement, resistance may be experienced and damage such as offset coil winds may occur.During functional testing, the smart coil was advanced through its introducer sheath without an issue but was unable to advance through the hub of a demonstration microcatheter due to the offset coil winds.Further evaluation revealed pusher assembly bends.These bends were likely incidental to the reported complaint.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: 9522032
• Report Number: 3005168196-2019-02405
• Device Sequence Number: 18966437
• Product Code: HCG
• UDI-Device Identifier: 00814548015637
• UDI-Public: 00814548015637
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2019
• 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: 10/14/2023
• Device Model Number: 400SMTHXSFT1H01
• Device Catalogue Number: 400SMTHXSFT1H01
• Device Lot Number: F86446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005