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

Catalog Number	400SMTSFT0410
Medical Device Problem Codes	Difficult or Delayed Separation (4044); Premature Separation (4045)
Health Effect - Clinical Codes	Hemorrhagic Stroke (4417); Ischemia Stroke (4418)
Date of Event	06/03/2022
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.Potential adverse events in the labeling with the penumbra smart coil system include, but are not limited to, embolic stroke and other cerebral ischemic events, neurological deficits including stroke, premature device detachment, ischemia, including death.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 anterior communication artery (acomm) using a penumbra smart coil (smart coil), a penumbra smart coil handle (handle), and a non-penumbra microcatheter.During the procedure, the physician advanced the smart coil into the target vessel and attempted to detach it using the handle; however, the smart coil failed to detach.Subsequently, the physician attempted to detach the smart coil using a second handle and then manually; however, they were still unsuccessful.The physician then attempted to remove the smart coil; however, the microcatheter lost position and the smart coil unintentionally detached with part of the smart coil in the target vessel and the other part in the microcatheter.Therefore, the physician pushed part of the smart coil into the target vessel and placed a stent to protect the parent vessel.The procedure was ended at this point.It was reported that the patient¿s health condition declined due to a small anterior cerebral artery (aca) territory infarct that was noted during a follow-up ct scan.The relationship between the smart coil and the infarct is unknown.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 3005168196-2022-00306.

• 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: 14847290
• Report Number: 3005168196-2022-00306
• Device Sequence Number: 2366882
• Product Code: HCG
• UDI-Device Identifier: 00814548015095
• UDI-Public: 814548015095
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 400SMTSFT0410
• Device Lot Number: F110143
• 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: 06/06/2022
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2021
• 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: Other; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005