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

Catalog Number 5MAXACE132

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2014

Event Type  malfunction  

Event Description

During preparation for a procedure, the physician was flushing a 5max ace reperfusion catheter prior to inserting into a neuron max and discovered that the flush was leaking out of a crack in the catheter approximately 1 cm distal to the hub.The physician used another 5max ace reperfusion catheter to complete the procedure.There was no adverse effect on the patient.

Manufacturer Narrative

Result: the proximal end of the 5max ace catheter shows a slight kink at the hypo tube strain relief.Under the strain relief the catheter is fractured approximately 1.5 cm from the hub.Conclusion: the device was returned for analysis and has been evaluated.The complaint indicates that the 5max ace catheter was being flushed prior to insertion into a neuron max and a leak was noticed.Evaluation of the returned device confirmed a fracture in the catheter shaft approximately 1.5 cm from the hub under the hypo tube strain relief.This fracture likely occurred as a result of improper removal of the product from the packaging during preparation for use.If the catheter is removed from the packaging tube at a severe angle, this type of damage may occur.These devices are 100% visually inspected during packaging.

Manufacturer Narrative

This device is available for return.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: 3651818
• MDR Text Key: 4355118
• Report Number: 3005168196-2014-00127
• 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: 01/29/2014

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: 02/28/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2014
• Initial Date FDA Received: 02/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/27/2014
• 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: 72 YR