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

Model Number	400SMTXSFT0306
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2020
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 using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).During the procedure, the physician experienced difficulty detaching a smart coil with the handle.Subsequently, the physician manually detached and implanted the smart coil in the target vessel.The procedure was completed using three additional smart coils and the same handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were inadvertently missed on the initial mfr report and are being included on this follow-up #02 mfr report:3005168196-2020-01279.Please note that the following statement in section h.Box 10./11.Narrative/corrected data on the follow-up #01 report incorrectly stated the following: "please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #a mfr report: 3005168196-2020-01279." the sentence above should have read as follows: "please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #1 mfr report: 3005168196-2020-01279.".
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).During the procedure, the physician experienced difficulty detaching a smart coil with the handle.Subsequently, the physician manually detached and implanted the smart coil in the target vessel.The procedure was completed using three additional smart coils and the same handle.There was no report of an adverse effect to the patient.
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 #a mfr report: 3005168196-2020-01279.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10451243
• Report Number: 3005168196-2020-01279
• Device Sequence Number: 3316999
• Product Code: HCG
• UDI-Device Identifier: 00814548015354
• UDI-Public: 00814548015354
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 07/31/2020
• 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: 04/08/2023
• Device Model Number: 400SMTXSFT0306
• Device Catalogue Number: 400SMTXSFT0306
• Device Lot Number: F82741
• 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: 07/31/2020
• Supplement Date Received by Manufacturer: 01/14/2005; 01/14/2005
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 08/26/2020; 09/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 62
• Date Report Sent to FDA: 01/01/2005