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

Model Number	400SMTSFT3H08
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
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: 3005168196-2021-00464, 3005168196-2021-00465.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra smart coils (smart coils) and a handle.During the procedure, two smart coils failed to detach using the same handle.The physician then attempted to manually detaching the two smart coils; however, was unsuccessful.Therefore, the two smart coils and handle were removed.The procedure was completed by manually detaching additional smart coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the first returned smart coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock, the pusher assembly was kinked and fractured, and the embolization coil was detached from the pusher assembly within the introducer sheath.If the pusher assembly mid-joint is retracted through the introducer sheath friction lock, resistance may be experienced during advancement.Forceful advancement against this likely contributed to the kink and fracture near the mid-joint.The detached embolization coil was likely a result of the fracture.The reported smart coil inability to detach during the procedure could not be confirmed.Evaluation of the second returned smart coil confirmed that the embolization coil was still intact with the pusher assembly.Further evaluation revealed that the pet lock was separated on the proximal end of the pusher assembly, the pull tube was fractured, the pusher assembly was kinked on its braided shaft, the pull wire was in its initial position within the pusher assembly ddt, coagulated blood was within the ddt, and the embolization coil had offset coil winds.The root cause of the pusher assembly kink and the coagulated blood could not be determined; however, this damage may contribute to resistance while retracting the pull wire.If the pull tube is forcefully retracted against this resistance, the pull wire may fracture, and the embolization coil will not detach.The offset coil winds 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.This report is associated with mfr report numbers: 1.3005168196-2021-00464, and 2.3005168196-2021-00465.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11446814
• Report Number: 3005168196-2021-00463
• Device Sequence Number: 19707280
• Product Code: HCG
• UDI-Device Identifier: 00814548017013
• UDI-Public: 00814548017013
• 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): 02/11/2021
• 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: 09/21/2025
• Device Model Number: 400SMTSFT3H08
• Device Catalogue Number: 400SMTSFT3H08
• Device Lot Number: F100465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 65
• Date Report Sent to FDA: 01/01/2005