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

Model Number	400SMTXSFT0304
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2020
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.This report is associated with mfr report numbers: 3005168196-2021-00057, 3005168196-2021-00058, 3005168196-2021-00060.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior cerebral artery (aca) using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, the physician placed four smart coils into the target location using the microcatheter.Afterwards, four smart coils would not advance at all within their introducer sheaths.Therefore, the four smart coils were removed.The procedure was completed using additional smart coils and non-penumbra coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed offset coil winds near the proximal and distal ends of the embolization coil.If the introducer sheath is not properly aligned within the hub of the microcatheter prior to advancement, resistance may be encounter and damage such as offset coil winds may occur.During functional testing, the smart coil was unable to be advanced through its introducer sheath due to the offset coil winds on the embolization coil.Evaluation of the returned smart coil revealed offset coil winds near the proximal and distal ends of the embolization coil.If the introducer sheath is not properly aligned within the hub of the microcatheter prior to advancement, resistance may be encounter and damage such as offset coil winds may occur.During functional testing, the smart coil was unable to be advanced through its introducer sheath due to the offset coil winds on the embolization coil.Evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced while advancing the device.Forcefully advancing the device against this resistance may have contributed to the kinks and a subsequent fracture near the pusher assembly mid-joint, and a fracture near the proximal end of the introducer sheath.Further evaluation of the device revealed additional kinks on the pusher assembly.This damage was likely incidental to the complaint and may have occurred during packaging for the device returned.Evaluation of the returned smart coil revealed that the pet lock was separated, and the embolization coil was detached from the pusher assembly.Based on the complaint, this damage was likely incidental.The detached embolization coil was not returned for evaluation.The reported complaint could not be confirmed.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.This report is associated with mfr report numbers: 1.3005168196-2021-00057, 2.3005168196-2021-00058, 3.3005168196-2021-00060.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11144080
• Report Number: 3005168196-2021-00059
• Device Sequence Number: 13659107
• Product Code: HCG
• UDI-Device Identifier: 00814548015347
• UDI-Public: 00814548015347
• Combination Product (Y/N): Y
• Initial Reporter Country: PL
• 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): 12/15/2020
• 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: 06/01/2025
• Device Model Number: 400SMTXSFT0304
• Device Catalogue Number: 400SMTXSFT0304
• Device Lot Number: F98180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 01/09/2021
• Supplement Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 56
• Date Report Sent to FDA: 01/01/2005