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

Catalog Number 5MAXACE132

Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250)

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

Event Date 03/05/2015

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system 5max ace reperfusion catheter.Upon attaching a fluid bag to the ace catheter, the physician noticed saline leaking from the ace catheter.The ace catheter was detached and the procedure successfully continued using a new penumbra system 5max ace reperfusion catheter.

Manufacturer Narrative

Result: the 5max ace was fractured in the proximal shaft under the strain relief, approximately 1.0 cm from the hub, and kinked in the proximal shaft approximately 6.0 cm from the hub.Conclusion: the complaint has been evaluated.The complaint indicated there was a leak in the proximal shaft of the 5max ace.Evaluation of the returned device revealed a fracture and a kink in the proximal shaft.This type of damage typically occurs when the device is improperly handled during removal from packaging.If the catheter is removed from the packaging hoop at an angle, the shaft may fracture due to excess force and bending.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.

• 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: 4659393
• MDR Text Key: 5600707
• Report Number: 3005168196-2015-00322
• 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: Health Professional
• Type of Report: Initial
• Report Date: 03/05/2015

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: 10/31/2017
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F46741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2015
• Initial Date FDA Received: 04/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2014
• 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