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

Catalog Number PSS032

Device Problem Insufficient Information (3190)

Patient Problems Intracranial Hemorrhage (1891); Reocclusion (1985)

Event Date 07/29/2012

Event Type  Injury  

Event Description

The patient was undergoing a thrombectomy procedure in the right middle cerebral artery (mca) using a penumbra system reperfusion catheter 032 and separator 032.Before the procedure intravenous tissue plasminogen (iv t-pa) was not administered.During the procedure, a reperfusion catheter 032 was advanced to the m2 along with another manufacturer's guide wire and guiding catheter.Aspiration was done with a separator 032 and 4,000 units of heparin were injected.The patient developed symptomatic intracranial hemorrhage.The physician closely monitored the patient's condition but withheld any additional treatment.Approximately a week later, the patient had not recovered.The patient left the hospital approximately a month later.Physician comments: it could not be denied that the event was related to the penumbra system and the procedure, because hemorrhage occurred in the recanalized area.Recanalization in the occluded part was successful.

Manufacturer Narrative

Conclusion: on (b)(4) 2014, the manufacturer received the reporters name and title.No further information is available; therefore, the manufacturer is closing the case.

Manufacturer Narrative

Conclusion: 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 3005168196-2014-00401.Device was disposed of by the hospital.

• Brand Name: PENUMBRA SYSTEM SEPARATOR 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 ; 5107483200
• MDR Report Key: 3885102
• MDR Text Key: 4649908
• Report Number: 3005168196-2014-00402
• 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,Followup
• Report Date: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/28/2015
• Device Catalogue Number: PSS032
• Device Lot Number: F24771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2012
• 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): Other
• Patient Age: 79 YR
• Patient Weight: 64