MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER; NRY

Catalog Number PSC054

Device Problem Insufficient Information (3190)

Patient Problems Intimal Dissection (1333); Intracranial Hemorrhage (1891); Reocclusion (1985)

Event Date 08/30/2013

Event Type  Injury  

Event Description

The patient was undergoing a thrombectomy procedure in the right middle cerebral artery (mca - m1) using a penumbra system 5max reperfusion catheter and a 5max separator.Before the procedure, intravenous tissue plasminogen (iv t-pa) was not administered.During the procedure, a 5max reperfusion catheter was advanced to the target vessel along with another manufacturer's guide wire and guiding catheter.Aspiration was done with a 5max separator and recanalization was successful; however, occlusion reoccurred.The patient was given 500 units of heparin by injection.A percutaneous transluminal angioplasty was performed and 120,000 units of uk were injected into the selective artery.The second recanalization was successful; however, re-occlusion occurred again.While attempting to stent the patient, the patient developed intracranial hemorrhage caused by dissection.Craniotomy for removal of thrombus and angiography was performed and the patient recovered.Physician comments: re-occlusions possibly resulted from damage on the wall of the mca, which caused by the 5max.It could not be denied that the event was related to the penumbra system and the procedure.

Manufacturer Narrative

Conclusion: dissection/hemorrhage 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 3005168196-2014-00400.Device was disposed of by the hospital.

• Brand Name: PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER
• 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: 3885096
• MDR Text Key: 4676238
• Report Number: 3005168196-2014-00399
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K090752
• 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: 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: 04/30/2016
• Device Catalogue Number: PSC054
• Device Lot Number: F34680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2013
• 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: 57 YR
• Patient Weight: 50