MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Model Number	4006C0306
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2019
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: 3005168196-2019-02212.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left posterior communicating arteries (pcom) using penumbra coils 400 (pc400s) and a px slim delivery microcatheter (px slim).During the procedure, the physician successfully placed three pc400s in the target vessel.While advancing the next pc400 through a px slim, the physician experienced resistance, and the pc400 unintentionally detached with the major part hanging in the vessel; therefore, the physician successfully used a stent retriever device to remove the detached pc400, and the px slim was removed.The physician then continued the procedure and placed a non-penumbra microcatheter in the target vessel and attempted to pack the aneurysm with a penumbra smart coil (smart coil).However, there was no space left in the aneurysm to insert the smart coil, and therefore, the physician decided to end the procedure at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the initial mfr report and is being updated on this follow-up # 01 mfr report:3005168196-2019-02211.1.Section b.Box 2.Outcomes attributed to adverse event this report is associated with mfr report number: 1.3005168196-2019-02212.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9396749
• Report Number: 3005168196-2019-02211
• Device Sequence Number: 2752289
• Product Code: HCG
• UDI-Device Identifier: 00814548011837
• UDI-Public: 00814548011837
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2019
• 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: 08/02/2025
• Device Model Number: 4006C0306
• Device Catalogue Number: 4006C0306
• Device Lot Number: F78519
• 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: 11/04/2019
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Date Report Sent to FDA: 01/01/2005