MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM REPERFUSION CATHETER 032; NRY

Catalog Number PSC032

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage, Cerebral (1889); Paresis (1998); Loss of consciousness (2418)

Event Date 01/18/2013

Event Type  Injury  

Event Description

The patient was undergoing a thrombectomy procedure in the right m1 using the penumbra system 032 and 041 reperfusion catheter and separator 032 and 041.Before the procedure, the physician decided not to administer tissue plasminogen activator (t-pa) to the patient.Stenting for the right ica stenosis was conducted.An optimo guide catheter 7fr.Was deployed and a reperfusion catheter 041 and 032 were advanced to the target vessel.Aspiration was conducted with a separator 041 and reperfusion catheter 041, then the separator 032 and reperfusion catheter 032 for 15 minutes.The patient was then given 5,000 units of heparin and 24,000 units of uk were injected into the selective artery.Treatment with a merci retriever was also performed.The patient developed extensive intracerebral hemorrhage (ich) in the right mca region and suffered consciousness disorder with paresis in the left arm and leg.The following day, the patient underwent external decompression and approximately 4 months later, the patient left the hospital.Physician's comment: since the hemorrhage occurred inside the cerebral infarct without perforation, the cause of the event was not directly related to the penumbra system.However, i cannot outright deny the relation because the hemorrhage happened after the recanalization.

Manufacturer Narrative

Hemorrhage is a known and anticipated complication with these types of procedures and is 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 3005168196-2014-00062, 00064 and 00065.Device disposed of by the hospital.

• Brand Name: PENUMBRA SYSTEM REPERFUSION CATHETER 032
• Type of Device: NRY
• 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 ; 5107483262
• MDR Report Key: 3586174
• MDR Text Key: 4031699
• Report Number: 3005168196-2014-00063
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/26/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2014
• Device Catalogue Number: PSC032
• Device Lot Number: F22537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2011
• 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: 66 YR
• Patient Weight: 60