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

Catalog Number	4006C0202
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2016
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 numbers: 1.3005168196-2016-00193, 2.3005168196-2016-00194, 3.3005168196-2016-00195, 4.3005168196-2016-00196, 5.3005168196-2016-00197.The device was implanted in the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the a2 segment of the cerebral artery using penumbra coil 400 coils (pc400 coils), a px slim delivery microcatheter (px slim) and penumbra coil detachment handles (handle).During the procedure, while advancing a pc400 coil (lot # f63825) through the px slim, the physician met resistance and decided to remove both the px slim and the pc400 coil.After removing both devices from the patient, the physician noticed that the pc400 coil was damaged and had unintentionally detached from the pusher assembly.A new pc400 coil (lot # f63825) was then deployed into the aneurysm using a new px slim without any issues; however, the physician had difficulty detaching the pc400 coil in the aneurysm using the handle (lot # f31442).After three unsuccessful attempts to detach the pc400 coil using the handle, the physician attempted to use a new handle (lot # f31442) but was still unsuccessful.The pc400 coil was then detached manually by the physician.Another pc400 coil (lot # f36541) was then deployed into the aneurysm; however, the physician was unable to detach the coil using the handle and decided to manually detach the coil.The procedure was completed at this point since the physician considered the aneurysm to have been properly filled with the two pc400 coils.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: 5445493
• Report Number: 3005168196-2016-00198
• Device Sequence Number: 18920254
• Product Code: HCG
• UDI-Device Identifier: 00814548011769
• UDI-Public: 00814548011769
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/20/2016

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: 07/31/2018
• Device Catalogue Number: 4006C0202
• Device Lot Number: F36541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2016
• Initial Report FDA Received Date: 02/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR