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

Catalog Number PSC054

Device Problem Insufficient Information (3190)

Patient Problem Intimal Dissection (1333)

Event Date 08/23/2013

Event Type  Injury  

Event Description

The patient was undergoing a thrombectomy procedure in the left internal carotid artery (ica) using a penumbra system 5max reperfusion catheter and 5max separator.Prior to the procedure, intravenous tissue plasminogen activator (t-pa) was not administered.The 5max reperfusion catheter was advanced with another manufacturer's retrieval device and aspiration was performed with a 5max separator.The patient was given 3,000 units of heparin.During the procedure, dissection occurred in the cervical part of the ica and treatment was withheld.Embolization reoccurred and stenting was performed successfully.The patient recovered.Physician's comment: it was also likely that another manufacturer's retrieval device caused the dissection.The relation between the event and the penumbra system was not deniable.

Manufacturer Narrative

Conclusion: dissection 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 3005168196-2014-00628.The hospital discarded the device.

• 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: 4078782
• MDR Text Key: 4746924
• Report Number: 3005168196-2014-00627
• 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: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: F34521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2014
• Initial Date FDA Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2013
• 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: 79 YR
• Patient Weight: 37