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

Model Number	400SMTHXSFT2H04
Medical Device Problem Codes	Separation Failure (2547); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid-posterior communicating artery using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle) and a non-penumbra microcatheter.It was noted that the patient anatomy was tortuous and calcified.During the procedure, the physician successfully placed two smart coils in the target vessel using the microcatheter.While attempting to place the next smart coil into the aneurysm the physician experienced resistance.The physician then put the distal end of the microcatheter against the aneurysm and pushed the smart coil in it.Subsequently, the physician attempted to detach the smart coil using the handle; however, the smart coil failed to detach.The physician then attempted to detach the smart coil again after withdrawing the microcatheter a little, but the smart coil would not detach.Therefore, the smart coil was removed.The procedure was completed using three non-penumbra coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil confirmed that the embolization coil did not detach from the pusher assembly.Evaluation revealed that the pet lock was separated; however, the pull wire was not fully retracted from the ddt.If the pull wire was not fully retracted from the ddt, the embolization coil will not detach from the pusher assembly.The root cause of the pull wire not being fully retracted from the ddt could not be determined.The separated pet lock was likely a result of coil detachment attempted during the procedure.During functional testing, the smart coil was unable to be detached with a demonstration handle due to the coagulated blood inside the ddt.Therefore, manual detachment was attempted, and the smart coil was able to be manually detached with resistance due to the coagulated blood inside the ddt.The coagulated blood inside the ddt was likely incidental to the complaint.Further evaluation of the device revealed offset coil winds on the embolization coil.This damage was likely incidental to the 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 number: 3005168196-2021-02560.

• 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: 12817042
• Report Number: 3005168196-2021-02561
• Device Sequence Number: 17332759
• Product Code: HCG
• UDI-Device Identifier: 00814548015750
• UDI-Public: 00814548015750
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2021
• 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: 04/29/2026
• Device Model Number: 400SMTHXSFT2H04
• Device Catalogue Number: 400SMTHXSFT2H04
• Device Lot Number: F105863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• 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: 10/21/2021
• Initial Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2021
• 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: 49 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005