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

Catalog Number 5MAXACE132

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Device Operates Differently Than Expected (2913)

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

Event Date 11/26/2014

Event Type  malfunction  

Manufacturer Narrative

Result: the 5max ace reperfusion catheter was fractured approximately 1.0 cm from the hub, underneath the strain relief.The 5max ace reperfusion catheter was kinked approximately 60.5 cm from the distal tip.Conclusion: the complaint has been evaluated.The complaint indicated a fracture in the proximal shaft of the 5max ace reperfusion catheter.Evaluation of the returned product confirmed the complaint.This type of damage typically occurs when the device is improperly handled during removal from the packaging or during preparation for use.If the catheter is removed from the packaging hoop or manipulated during insertion into the patient at an angle, the shaft may fracture due to excess force and bending of the catheter.These devices are 100% visually inspected for damage during process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system 5max ace reperfusion catheter.During preparation, the physician heard a whistling noise and noticed that air was accumulating in the rotating hemostatic valve (rhv).The physician flushed the catheter and saline squirted from a fracture in the hub.The physician used a new catheter to complete the procedure.

Manufacturer Narrative

Conclusion: the device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

• Brand Name: PENUMBRA SYSTEM 5MAX ACE 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: 4357581
• MDR Text Key: 13214902
• Report Number: 3005168196-2014-00908
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/26/2014

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: 09/30/2017
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F45869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2015
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2014
• 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