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

Catalog Number	4006C0306
Medical Device Problem Codes	Retraction Problem (1536); Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	06/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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: 3005168196-2016-01019.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left internal carotid artery (ica) using penumbra coil 400 coils (pc400 coils).During the procedure, the physician advanced a px slim delivery microcatheter (px slim) into the left ica and then placed another manufacturer's stent device in the neck portion of the aneurysm.While using the jailing technique to perform the procedure, the physician advanced a pc400 coil approximately ten centimeters through the px slim and then met resistance.Therefore, the physician removed the pc400 coil and continued the procedure by deploying and detaching thirteen pc400 coils into the aneurysm using the same px slim.While attempting to deliver a new pc400 coil, the physician met resistance after the coil was slightly advanced out of the px slim.The physician then attempted to retract the coil but also met resistance.Therefore, the physician attempted to remove the px slim containing the pc400 coil; however, the coil unintentionally detached around the common carotid artery and migrated towards the distal vessels.Consequently, the physician required a snare device to retrieve the detached pc400 coil from the patient.The procedure was successfully completed with no further issues.It should be noted that flushing was performed throughout the procedure.One day post procedure, thrombosis in the distal vessels was confirmed.It is unknown if the thrombosis was caused by the pc400 coil that migrated towards the distal vessels or by the other manufacturer's stent device that was used at the same time.However, upon review of an image that was taken when the pc400 coil unintentionally detached, the physician confirmed that a thin thread-like object was protruding from the coil filaments.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5810556
• Report Number: 3005168196-2016-01020
• Device Sequence Number: 16303287
• Product Code: HCG
• UDI-Device Identifier: 00814548011837
• UDI-Public: 00814548011837
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2016

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: Physician
• Device Expiration Date: 02/23/2024
• Device Catalogue Number: 4006C0306
• Device Lot Number: F68079
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2016
• Initial Report FDA Received Date: 07/20/2016
• 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: Life Threatening; Other; Required Intervention
• Patient Age: 60 YR