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

Catalog Number 4002C2060

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Therapeutic Response, Decreased (2271)

Event Date 03/05/2015

Event Type  Injury  

Event Description

The patient underwent a coil embolization procedure in the left splenic artery using penumbra coil 400 (pc400) coils and ruby coils.Six months following the procedure, the aneurysm was found recanalized.At a follow-up appointment, the patient complained of abdominal pain and underwent a splenectomy procedure.The event has a probable relationship to the pc400 coils and ruby coils, unrelated to the angiographic procedure, and unrelated to the disease state.

Manufacturer Narrative

Recanalization is a known and anticipated complication with these types of procedures and are noted in the device labeling.Therefore, it was determined that the reported event was an anticipated procedural complication.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This mdr is associated with mdr 3005168196-2015-00448, 00449, 00450, 00451, 00452, 00453, 00454, 00455, 00457, 00458, 00459, 00460, and 00461.The hospital discarded the device.

• Brand Name: PENUMBRA COIL 400
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; 1351 harbor bay parkway; alameda, CA 94502 ; 5107483200
• MDR Report Key: 4760951
• MDR Text Key: 5779794
• Report Number: 3005168196-2015-00456
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 4002C2060
• Device Lot Number: F27006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR