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

Model Number	4002C1245
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	07/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) to treat a pseudo-aneurysm using penumbra coil 400s (pc400s) and a px slim delivery microcatheter (px slim).During the procedure, the physician successfully implanted two coils.While introducing a pc400 to the target vessel, the physician encountered slight resistance before it prematurely detached.It was reported that one third of the coil was in the aneurysm and the rest was contained in the px slim.Therefore, the physician used a non-penumbra stent retriever and a non-penumbra device to successfully retrieve the pc400.The procedure was completed using a non-penumbra stent device and the same px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device associated with this report was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was discarded.Therefore, without the return of the device, the root cause of the problem cannot be determined.Based on this information, corrections were made to: section d.Box 10.Device available for evaluation? (do not send to fda); section h.Box 3.Reason for non-evaluation; section h.Box 3.''other'' reason for non-evaluation.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10440538
• Report Number: 3005168196-2020-01268
• Device Sequence Number: 14187706
• Product Code: HCG
• UDI-Device Identifier: 00814548010649
• UDI-Public: 00814548010649
• Combination Product (Y/N): Y
• Initial Reporter Country: ID
• 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): 07/30/2020
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/10/2021
• Device Model Number: 4002C1245
• Device Catalogue Number: 4002C1245
• Device Lot Number: C14477
• 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: 07/30/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 08/22/2020
• Supplement Report FDA Received Date: 12/23/2020
• 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: 22 YR
• Date Report Sent to FDA: 01/01/2005