MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 4MAX SEPARATOR; NRY

Catalog Number PSF041

Device Problems Material Separation (1562); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2013

Event Type  malfunction  

Event Description

The patient was undergoing a neurothrombectomy procedure in the left mca using the penumbra system 4max.During the procedure, a 4max catheter was approached from the right femoral artery to the front of the thrombus in the m1.The thrombus was so hard that a micro guide wire could not pierce it.The micro guide wire was replaced with a 4max separator to aspirate but the 4max separator could not pierce it either.The 4max separator was pulled out of the body and the physician found that the distal part was broken up.Fluoroscope showed the distal part of the 4max separator was left inside the 4max catheter.The physician withdrew the distal part of the separator and the 4max catheter.The physician verified that there was no part of the device inside the patient and completed the procedure.Physicians comment: i felt resistance while pulling back the 4max separator.I cannot tell whether it got stuck with thrombus inside the 4max catheter or stuck due to the tortuous vessel.

Manufacturer Narrative

Conclusion: this device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

• Brand Name: PENUMBRA SYSTEM 4MAX SEPARATOR
• 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: 3563066
• MDR Text Key: 4073135
• Report Number: 3005168196-2014-00022
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100769
• 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: 12/10/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician Assistant
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: PSF041
• Device Lot Number: F35912
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2013
• Initial Date FDA Received: 01/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2013
• 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 Age: 44 YR