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

Catalog Number	400SMTXSFT0203
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the posterior communication artery (pcom) using a penumbra smart coil (smart coil) a penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician advanced the smart coil in the target vessel using the microcatheter and attempted to detach it using the handle; however, the smart coil failed to detach.The physician then made multiple attempts to manually detach the smart coil in three different locations of the pusher assembly; however, it would not detach.Therefore, the physician decided to retract the smart coil.While retracting, the smart coil unintentionally detached with part of the smart coil in the aneurysm and the other part in the microcatheter.Next, the physician advanced the microcatheter to push the remaining part of the smart coil into the aneurysm; however, the microcatheter was displaced into the parent vessel.The physician decided to leave the coil partially in the aneurysm and partially in the parent vessel.The procedure had ended at this point.There was no report of an adverse effect to the patient.
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.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the initial mfr report and is being included on this follow-up #01 mfr report:3005168196-2023-00061.Section h.Box 4.Device manufacture date 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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 16287641
• Report Number: 3005168196-2023-00061
• Device Sequence Number: 5019702
• Product Code: HCG
• UDI-Device Identifier: 00814548015279
• UDI-Public: 814548015279
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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,Followup
• Report Date (Section B): 05/04/2023
• 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 Catalogue Number: 400SMTXSFT0203
• Device Lot Number: F112857
• 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: 01/09/2023
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• 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: 80 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005