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

Model Number	400SMTHXSFT0306
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
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.This report is associated with mfr report number: 3005168196-2021-02082.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, it was reported that one smart coil failed to detach in the target location using the handle and another smart coil would not advance into the microcatheter.Therefore, both smart coils were removed.The procedure was completed using new smart coils and the same handle.There was no adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the first returned smart coil confirmed that the embolization coil was intact.Further evaluation revealed the pusher assembly was fractured and kinked on its proximal end.If the pusher assembly is kinked, the pull wire may become pinned within the hypotube causing resistance.During functional testing, the pull wire was retracted manually on the proximal end of the pusher assembly with resistance due to the pusher assembly kink, and the embolization coil was able to be detached.The pusher assembly kink may have contributed to smart coils inability to detach during the procedure.Further evaluation revealed offset coil winds on the embolization coil.This damage was likely incidental to the reported complaint.Evaluation of the second returned smart coil revealed a kink in the distal end of the introducer sheath.If the introducer sheath is mishandled at extreme angles during use, damage such as this may occur.During functional testing, the smart coil was advanced through its introducer sheath with resistance due to the introducer sheath kink.The smart coil was then advanced through a demonstration microcatheter with resistance due to the pusher assembly kinks that were present along the device.The pusher assembly kinks may be incidental to the reported complaint and may have occurred during packaging the device for return to penumbra.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.This report is associated with mfr report number: 3005168196-2021-02082.H3 other text : placeholder.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12493464
• Report Number: 3005168196-2021-02083
• Device Sequence Number: 11072686
• Product Code: HCG
• UDI-Device Identifier: 00814548015781
• UDI-Public: 00814548015781
• Combination Product (Y/N): Y
• Initial Reporter State: AR
• 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,Followup
• Report Date (Section B): 10/13/2021
• 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: 04/15/2024
• Device Model Number: 400SMTHXSFT0306
• Device Catalogue Number: 400SMTHXSFT0306
• Device Lot Number: F89649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 09/19/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Date Report Sent to FDA: 01/01/2005