MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM REPERFUSION CATHETER 041; NRY

Catalog Number PSC041

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Perforation (2001)

Event Date 10/05/2012

Event Type  Injury  

Event Description

The patient was undergoing a thrombectomy procedure in the basilar artery (ba) using a penumbra system reperfusion catheter 041 and separator 041.Before the procedure, the physician did not administer intravenous tissue plasminogen (iv t-pa).During the procedure, the reperfusion catheter 041 was advanced to the ba along with a transcend ex 0.014 inch through a fubuki 7fr.Neurovascular guiding catheter.Aspiration was done with a separator 41 and 5,000 units of heparin were injected.Perforation with the separator 041 caused asymptomatic encephalorrhagia; therefore, the patient underwent spinal drainage.Approximately, 12 days later from the drainage, the patient left the hospital.Physician's comment: i placed the distal tip of the psc041 in the ba top to aspirate from there.I perforated the artery with the pss041 while inserting it.The event was related to the penumbra system and the procedure.I consider this event as a serious adverse event, hospitalization.

Manufacturer Narrative

Conclusion: perforation 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 3005168196-2014-00260.Device was disposed of by the hospital.

• Brand Name: PENUMBRA SYSTEM REPERFUSION CATHETER 041
• 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: 3785407
• MDR Text Key: 4446071
• Report Number: 3005168196-2014-00259
• 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: 04/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: PSC041
• Device Lot Number: F25104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2012
• 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): Required Intervention
• Patient Age: 77 YR