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

Model Number	400SMTSFT4H10
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
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: 3005168196-2022-00102.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right posterior cerebral artery using penumbra smart coils (smart coil), penumbra smart coil detachment handles (handle), a non-penumbra microcatheter, and a guidewire.During the procedure, the physician advanced a smart coil (f109435) as the first coil to the target vessel and attempted to detach it using a handle; however, the coil failed to detach.The physician then pulled back on the microcatheter and attempted again to detach the smart coil using the handle; however, the coil still would not detach.Subsequently, the handle was not used for the remainder of the procedure, and the smart coil also failed to detach using a second handle.Therefore, the physician decided to remove the smart coil from the microcatheter.While retracting the smart coil from the microcatheter, the coil unintentionally detached partially in the microcatheter and partially in the aneurysm.The physician decided to leave the smart coil in place since most of the smart coil was in the aneurysm and only the tail of the coil remained outside of the aneurysm.Next, the physician advanced another smart coil (f102575) to the aneurysm and attempted to detach it using the second handle; however, the smart coil failed to detach.While retracting the smart coil, the smart coil unintentionally detached within the microcatheter.Therefore, the microcatheter containing the detached smart coil was removed, and a new non-penumbra microcatheter was advanced into the aneurysm.Then, the physician advanced another smart coil (f100967) to the aneurysm using the second microcatheter and attempted to detach it using the second handle; however, the coil failed to detach.Subsequently, the second handle was not used for the remainder of the procedure, and the smart coil also failed to detach using a third handle.Therefore, the smart coil was removed without issue.The same issue occurred while attempting to detach one additional smart coil (f106748) in the aneurysm using the third handle.Therefore, the smart coil was also removed without issue.The procedure was completed using non-penumbra coils and the second 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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 13675842
• Report Number: 3005168196-2022-00103
• Device Sequence Number: 4755507
• Product Code: HCG
• UDI-Device Identifier: 00814548017051
• UDI-Public: 00814548017051
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2022
• 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: 12/06/2025
• Device Model Number: 400SMTSFT4H10
• Device Catalogue Number: 400SMTSFT4H10
• Device Lot Number: F102575
• Was Device Available for Evaluation?: No
• 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: 02/09/2022
• Initial Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2020
• 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: 50 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005