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

Model Number	400SMTSTD1260
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
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: 3005168196-2021-00821, 3005168196-2021-00822, 3005168196-2021-00824.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a basilar aneurysm using penumbra smart coils (smart coil), penumbra smart coil detachment handle (handle), non-penumbra coils, non-penumbra sheath, and a non-penumbra microcatheter.During the procedure, the physician first placed other coils in the target vessel using the microcatheter.While attempting to place the first smart coil in the target location, the physician noticed the smart coil was stuck and would not advance out of its introducer sheath; therefore, it was removed.Subsequently, two new smart coils were placed and detached in the target vessel using the handle.While attempting to place another smart coil, the same issue occurred, and the smart coil was stuck and would not advance out of its introducer sheath.Therefore, it was removed.Afterwards, the physician advanced another smart coil in the target location and attempted to detach it using the handle; however, the smart coil failed to detach.An attempt was made to manually detach the pusher assembly of the smart coil, but the coil still failed to detach.Therefore, the physician decided to remove the smart coil.However, while retracting, the smart coil detached inside the microcatheter.Subsequently, the physician used a guidewire to push the detached smart coil into the aneurysm.It was also reported that at this point the handle was removed and exchanged for a new handle.Another smart coil was then placed in the target location; however, while attempting to advance the final smart coil into the target location, the physician experienced resistance and the smart coil would not advance into the aneurysm.Therefore, it was removed.The procedure was completed using other 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: 11710274
• Report Number: 3005168196-2021-00823
• Device Sequence Number: 17143575
• Product Code: HCG
• UDI-Device Identifier: 00814548014449
• UDI-Public: 00814548014449
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• 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
• Report Date (Section B): 03/24/2021
• 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: 02/16/2025
• Device Model Number: 400SMTSTD1260
• Device Catalogue Number: 400SMTSTD1260
• Device Lot Number: F96301
• 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: 03/24/2021
• Initial Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Date Report Sent to FDA: 01/01/2005