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

Model Number	400SMTXSFT3H06
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
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: 3005168196-2021-00577, 3005168196-2021-00579.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the posterior communicating artery (pcom) using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle) and a non-penumbra microcatheter.During the procedure, the physician placed a smart coil in the target vessel using the microcatheter and detach it using the handle.The physician then advanced a second smart coil in the target vessel using the microcatheter and attempted to detach it using the handle; however, the physician noticed via an angiogram that the smart coil failed to detach.The physician then made two additional attempts to detach the smart coil using the handle; however, the smart coil failed to detach.Therefore, the smart coil was manually detached.Subsequently, the physician advanced two additional smart coils into the target vessel and attempted to detach them using the handle; however, the same issue occurred.The physician made additional attempts to click the handle and both smart coils eventually detached successfully.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were inadvertently missed on the initial mfr report and are being included on this follow-up #01 mfr report: 3005168196-2021-00578.1.Section a.Box 2.Age at time of event, age unit.2.Section a.Box 3.Sex.This report is associated with mfr report numbers: 1.3005168196-2021-00577.2.3005168196-2021-00579 h3 other text : placeholder.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11566906
• Report Number: 3005168196-2021-00578
• Device Sequence Number: 3598669
• Product Code: HCG
• UDI-Device Identifier: 00814548017112
• UDI-Public: 00814548017112
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2021
• 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: 07/01/2023
• Device Model Number: 400SMTXSFT3H06
• Device Catalogue Number: 400SMTXSFT3H06
• Device Lot Number: F84423
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 05/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Date Report Sent to FDA: 01/01/2005