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

Catalog Number PSF054

Device Problems Break (1069); Difficult to Insert (1316)

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

Event Date 12/12/2013

Event Type  malfunction  

Event Description

The patient was undergoing a revascularization procedure for treatment of an embolism in the left ica.The physician placed the guide catheter in the femoral artery followed by the penumbra system 5max reperfusion catheter.Partial recanalization in the ica was achieved with the 5max reperfusion catheter.The guide catheter balloon was damaged so the physician decided to insert a merci microcatheter through the 5max reperfusion catheter.After piercing the thrombus one time with the merci retriever v 2.5 firm, the physician was unable to re-insert the 5max reperfusion catheter back into the guide catheter.The physician advanced the merci microcatheter to the left mca and pierced the thrombus two times with the merci retriever v 2.5 firm but recanalization was unsuccessful.The physician then used a merci retriever v 3.0 firm and had successful partial recanalization.Because the physician could not insert the 5max reperfusion catheter into the guide catheter, he decided to push the 5max reperfusion catheter without the guide catheter.The physician then could not insert the merci microcatheter or the penumbra system separator 5max into the 5max reperfusion catheter.The physician then decided to withdraw all devices and finish the procedure.

Manufacturer Narrative

This device was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, quality, or design concerns.This mdr is associated with mdr 3005168196-2014-00037.Hospital disposed of device.

• Brand Name: PENUMBRA SYSTEM SEPARATOR 5MAX
• 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: 3579785
• MDR Text Key: 4031061
• Report Number: 3005168196-2014-00038
• 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: 12/17/2013

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
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: PSF054
• Device Lot Number: F34941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2013
• Initial Date FDA Received: 01/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2013
• 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: 79 YR