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

Catalog Number	4006C0308
Medical Device Problem Codes	Detachment Of Device Component (1104); Premature Activation (1484); Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2016
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.This report is associated with mfr report number: 3005168196-2016-00755.The device was implanted into the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the distal vertebral artery (dva) using penumbra coil 400 coils (pc400 coils).Prior to placing coils into the patient, the physician implanted three flow diverting stents from another manufacturer via the right vertebral artery.The aneurysm sac was then accessed via the left vertebral artery for coil embolization.While attempting to advance an initial pc400 coil into the px slim delivery microcatheter (px slim), the physician had difficulty advancing the coil out of its introducer sheath.Upon further manipulation, the physician was still unable to advance the pc400 coil and therefore, the coil was removed.The procedure continued using additional pc400 coils.While attempting to place the last pc400 coil into the dva, the physician retracted the coil and subsequently, the coil unintentionally detached.The pc400 coil extended down from the vertebral/basilar junction approximately six centimeters to the proximal vertebral artery.The procedure was completed at this point with no immediate adverse effects noted.The patient had a follow up angiogram two days post procedure which revealed that the pc400 coil was still in the same location and did not appear to have migrated.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5704005
• Report Number: 3005168196-2016-00756
• Device Sequence Number: 13478481
• Product Code: HCG
• UDI-Device Identifier: 00814548011851
• UDI-Public: 00814548011851
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/09/2016

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: Physician
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 4006C0308
• Device Lot Number: F60768
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2016
• Initial Report FDA Received Date: 06/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 159