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

Catalog Number	400SMTXSFT1H03
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle meningeal artery (mma) using penumbra smart coils (smart coil), a penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician advanced the first smart coil into the target vessel and attempted to detach it using a handle; however, the smart coil failed to detach.Therefore, the physician switched to a new handle and detached the smart coil.The physician then advanced a second smart coil into the vessel and was unable to detach it using both handles.Therefore, the physician used his fingers to pull the pusher assembly and manually detached the smart coil.Next, while advancing a smart coil through the microcatheter and into another branch of the mma, the physician experienced resistance and decided to remove the smart coil.However, upon removing the pusher assembly of the smart coil out from the microcatheter, the physician noticed the smart coil had unintentionally detached inside the microcatheter.Therefore, the microcatheter containing the detached smart coil was removed and the coil was flushed out.The physician reinserted the microcatheter and placed a new smart coil in the vessel.Afterwards, the physician advanced another smart coil into the target vessel and made multiple attempts to detach it using both handles; however, the smart coil failed to detach.The physician attempted to manually detach the coil, but the smart coil would not detach.Therefore, a forceps was used to detach the smart coil.Subsequently, the same issue occurred with the last smart coil.The physician, therefore used a forceps to detach the last smart coil.The procedure had ended at this point.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: 15611773
• Report Number: 3005168196-2022-00477
• Device Sequence Number: 7149834
• Product Code: HCG
• UDI-Device Identifier: 00814548015231
• UDI-Public: 814548015231
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/14/2022
• 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: 12/21/2025
• Device Catalogue Number: 400SMTXSFT1H03
• Device Lot Number: F102923
• 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: 09/21/2022
• Initial Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2020
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005