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

Model Number	400SMTXSFT2H08
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2021-02232, 3005168196-2021-02234.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right middle cerebral artery (mca) using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician successfully deployed and detached a smart coil into the target vessel using the handle.The physician then advanced the next smart coil in the target vessel using the microcatheter and attempted to detach it using the handle; however, the smart coil failed to detach.Therefore, the smart coil was removed.Next, the physician advanced another smart coil in the target vessel using the microcatheter and attempted to detach it using the handle; however, the same issue occurred.The smart coil failed to detach.Therefore, the smart coil was also removed.Subsequently, the physician successfully deployed and detached another smart coil into the target vessel using the handle.Afterwards, the physician advanced another smart coil into the target vessel using the microcatheter and attempted to detach it using the handle; however, the smart coil failed to detach.Therefore, the smart coil was removed.The procedure was completed using new smart coils, the same handle, non-penumbra coils, and the same microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12602385
• Report Number: 3005168196-2021-02233
• Device Sequence Number: 3193495
• Product Code: HCG
• UDI-Device Identifier: 00814548015576
• UDI-Public: 00814548015576
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2021
• 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: 06/22/2022
• Device Model Number: 400SMTXSFT2H08
• Device Catalogue Number: 400SMTXSFT2H08
• Device Lot Number: F77854
• Was Device Available for Evaluation?: No
• 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: 09/13/2021
• Initial Report FDA Received Date: 10/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Date Report Sent to FDA: 01/01/2005