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

Model Number	4004C1335-A
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2020
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 a penumbra coil 400 (pc400) and a microcatheter.During the procedure, while advancing the pc400 into the aneurysm using the microcatheter, the pc400 unintentionally detached inside the microcatheter with the majority if the pc400 inside the aneurysm.Therefore, the remaining pc400 was successfully pushed into the aneurysm.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure treat an arteriovenous malformation (avm) using a penumbra coil 400 (pc400) and a microcatheter.It was noted that the patient anatomy was tortuous.During the procedure, while advancing the pc400 into the aneurysm using the microcatheter, the pc400 unintentionally detached inside the microcatheter with the majority if the pc400 inside the aneurysm.Therefore, the pusher assembly of the pc400 was used to successfully push the remaining pc400 into the aneurysm.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 02/13/2020: 1.Section b.Box 5.Describe event or problem.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9702413
• Report Number: 3005168196-2020-00173
• Device Sequence Number: 2824747
• Product Code: HCG
• UDI-Device Identifier: 00814548019024
• UDI-Public: 00814548019024
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• 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): 01/18/2020
• 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 Model Number: 4004C1335-A
• Device Catalogue Number: 4004C1335
• Device Lot Number: F91593
• 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: 01/18/2020
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005