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

Catalog Number 5MAXACE132

Device Problems Fluid/Blood Leak (1250); Device Contamination with Body Fluid (2317); Device Operates Differently Than Expected (2913)

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

Event Date 11/06/2014

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure in the middle cerebral artery using a penumbra system 5max ace reperfusion catheter.Upon turning on the aspiration pump, blood and contrast agent began leaking from the helical enhancement in the proximal shaft of the penumbra system 5max ace reperfusion catheter.The procedure continued and aspiration was not affected, yet aspiration was ineffective and a stent device was required.The was no report of an adverse effect on the patient.

Manufacturer Narrative

Result: the 5max ace catheter was kinked approximately 1.0 cm from the hub underneath the strain relief.Conclusion: the complaint has been evaluated.The complaint indicates that the 5max ace catheter was leaking during aspiration.Evaluation of the returned product confirmed a kink in the proximal shaft of the catheter underneath the strain relief.The kink created a tear in the catheter polymer material which caused the device to leak.This type of damage typically occurs when the device is mishandled during removal from the packaging or during preparation for use.If the product was removed at an angle while force or pressure was being applied, this damage is likely to occur.These devices are 100% visually inspected for damage during inspection.The product lot number was not provided therefore the manufacturing records could not be reviewed.

• 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: 4317852
• MDR Text Key: 20065238
• Report Number: 3005168196-2014-00851
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K090752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2014

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 Catalogue Number: 5MAXACE132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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: 50 YR