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

Model Number	400SMTXSFT1H03
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2021
Type of Reportable Event	Serious Injury
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: 3005168196-2021-02770.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acomm) using penumbra smart coils (smart coil), penumbra smart coil detachment handles (handle) and a non-penumbra microcatheter.During the procedure, the physician placed and detached six smart coils in the target location.The physician then advanced another smart coil and made multiple attempts to detach it using the handle.After an audible click was heard and the black alignment zone had separated, the physician attempted to remove the pusher assembly; however, it was noted under fluoroscopy that the smart coil had not detached.Subsequently, while attempting to retract the smart coil, the physician encountered some resistance and the smart coil unintentionally detached partially within the microcatheter.The physician then tried to push the smart coil into the target location but was unsuccessful.Therefore, the physician used a stent to push the smart coil against the vessel wall.The procedure ended at this point.It was reported that an aneurysm rupture occurred after two smart coils had been placed.Subsequently, additional smart coils were placed to address the rupture.It was also reported that the patient expired due to the intra-procedure aneurysm rupture.

• 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: 12957938
• Report Number: 3005168196-2021-02769
• Device Sequence Number: 5424507
• Product Code: HCG
• UDI-Device Identifier: 00814548015231
• UDI-Public: 00814548015231
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/07/2021
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2026
• Device Model Number: 400SMTXSFT1H03
• Device Catalogue Number: 400SMTXSFT1H03
• Device Lot Number: F106794
• 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: 11/12/2021
• Initial Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005