MAUDE Adverse Event Report: PENUMBRA, INC. PAC400 COIL; HCG, KRD

Model Number	400PAC50
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2019
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 in the dural venous sinus using penumbra coil 400s (pc400).During the procedure, after advancing a pc400 into the target vessel using a px slim delivery microcatheter (px slim), the physician decided to retract the pc400 for repositioning.However, while retracting, the pc400 unintentionally detached from the pusher wire inside of the px slim.Therefore, the physician used a 20cc syringe to create negative pressure and removed the px slim with the coil inside.The procedure was then completed using a new pc400 and the same px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections are being corrected on this follow-up #1 report: 1.Section b.Box 5.: event description.2.Section d.Box 1.Brand name h3 other text : placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the dural venous sinus using pac400s (pac400).During the procedure, after advancing a pac400 into the target vessel using a px slim delivery microcatheter (px slim), the physician decided to retract the pac400 for repositioning.However, while retracting, the pac400 unintentionally detached from the pusher wire inside of the px slim.Therefore, the physician used a 20cc syringe to create negative pressure and removed the px slim with the coil inside.The procedure was then completed using a new pac400 and the same px slim.There was no report of an adverse effect to the patient.

• Brand Name: PAC400 COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9126493
• Report Number: 3005168196-2019-01827
• Device Sequence Number: 2820081
• Product Code: HCG
• UDI-Device Identifier: 00815948021341
• UDI-Public: 00815948021341
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2019
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 400PAC50
• Device Catalogue Number: 400PAC50
• Device Lot Number: C16106
• 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: 08/29/2019
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Date Report Sent to FDA: 01/01/2005