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

Model Number	400SMTXSFT0306
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle cerebral artery (mca) using penumbra smart coils (smart coil), a penumbra smart coil detachment handle (handle) and a non-penumbra microcatheter.During the procedure, while attempting to advance a smart coil into the microcatheter, the smart coil would not advance past its initial position within its introducer sheath.Subsequently, the pusher assembly became bent.Therefore, the smart coil was removed and replaced.Next, after placing four smart coils in the target location successfully, the physician attempted to detach the next smart coil using the handle; however, the smart coil failed to detach.Therefore, the handle was removed.The procedure was completed using a new handle and the same smart coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Forceful advancement against this resistance likely contributed to the kink observed near the pusher assembly mid-joint.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance.After the mid-joint passed through the friction lock, the smart coil was able to advance through its introducer sheath without an issue.Penumbra products 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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12863127
• Report Number: 3005168196-2021-02673
• Device Sequence Number: 4570988
• Product Code: HCG
• UDI-Device Identifier: 00814548015354
• UDI-Public: 00814548015354
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/23/2021
• 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: 02/02/2025
• Device Model Number: 400SMTXSFT0306
• Device Catalogue Number: 400SMTXSFT0306
• Device Lot Number: F96057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005