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

Model Number	400SMTHXSFT0203
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
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 number: 3005168196-2021-02324.
Event or Problem Description
On (b)(6) 2021, the patient was undergoing a coil embolization procedure in the middle cerebral artery (mca) using penumbra smart coils (smart coils).During the procedure, the physician placed one smart coil into the target location.While attempting to advance another smart coil within its introducer sheath, the smart coil would not advance at all from its initial position within its introducer sheath.Therefore, the smart coil was removed.The procedure was completed using additional smart coils.On (b)(6) 2021, the patient suffered several mini embolic subacute bihemispheric infarctions.The patient was started on 100 mg of acetylsalicylic acid daily.On (b)(6) 2021, information was received indicating that the event was resolved on (b)(6) 2021.On (b)(6) 2021, additional information was received indicating that on (b)(6) 2021 the patient was transferred to another hospital with slight psychomotor slowdown without focal neurologic signs and pain compensation.The several mini embolic subacute bihemispheric infarctions were reported to be a non-serious adverse event with a possible relationship to the smart coil and a probable relationship to the index procedure.
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced during advancement and the device may not be advanced out of the introducer sheath.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 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 number: 3005168196-2021-02324.

• 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: 12652674
• Report Number: 3005168196-2021-02323
• Device Sequence Number: 14506120
• Product Code: HCG
• UDI-Device Identifier: 00814548015705
• UDI-Public: 00814548015705
• Combination Product (Y/N): Y
• Initial Reporter Country: SZ
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2021
• 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: 03/14/2026
• Device Model Number: 400SMTHXSFT0203
• Device Catalogue Number: 400SMTHXSFT0203
• Device Lot Number: F104560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• 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: 09/15/2021
• Supplement Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2021
• 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: 53 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005