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

Model Number	400SMTSFT0610
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.Box 6.Device code (b)(4) the device problem "smart coil pushing back" is not adequately defined by another code.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) and posterior communicating artery (pcom) using penumbra smart coils.During the procedure, a smart coil pushed back.The procedure was completed using four more smart coils.Post-procedure, the patient was dosed with brilinta.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report: 3005168196-2020-00988.4.Section h.Box 6.Method code 1, method code 2 & method code 3.5.Section h.Box 6.Results code 1.6.Section h.Box 6.Conclusions code 1.Please note that the following sections are being updated based on additional information provided by a penumbra representative on 12/02/2020: 1.Section b.Box 5.Describe event or problem.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 internal carotid artery (ica) and posterior communicating artery (pcom) using penumbra smart coils.During the procedure, a loop of first smart coil was pushed back into the artery during the placement of second smart coil.The procedure was completed using four more smart coils.Post-procedure, the patient was dosed with brilinta.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: 10311736
• Report Number: 3005168196-2020-00988
• Device Sequence Number: 860573
• Product Code: HCG
• UDI-Device Identifier: 00814548014968
• UDI-Public: 00814548014968
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2020
• 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: 04/24/2022
• Device Model Number: 400SMTSFT0610
• Device Catalogue Number: 400SMTSFT0610
• Device Lot Number: C19737
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005