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

Model Number	400SMTSFT0615
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
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 number: 3005168196-2021-01399.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right 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, the physician advanced a smart coil into the aneurysm and attempted to detach it using the handle; however, the smart coil failed to detach.The physician then removed the handle and tried using two new handles to detach the same smart coil, but the smart coil still failed to detach.Therefore, the smart coil was removed.The physician then successfully placed a new smart coil into the aneurysm using the first handle.Afterwards, a new smart coil would not advance past the friction lock within its introducer sheath.Therefore, the smart coil was removed.The procedure was completed using another coil 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: 12054013
• Report Number: 3005168196-2021-01398
• Device Sequence Number: 4304421
• Product Code: HCG
• UDI-Device Identifier: 00814548014975
• UDI-Public: 00814548014975
• 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): 06/23/2021
• 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: 01/31/2026
• Device Model Number: 400SMTSFT0615
• Device Catalogue Number: 400SMTSFT0615
• Device Lot Number: F103585
• 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: 05/25/2021
• Initial Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Date Report Sent to FDA: 01/01/2005