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

Catalog Number 5MAXACE132

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

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

Event Date 03/03/2014

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system 5max ace reperfusion catheter.The physician noted that the 5max ace catheter had a hole adjacent to the hub, as it was leaking (before attaching the tube for aspiration).Due to the catheter being in the patient, the physician decided to use it while putting pressure on the hole with his finger.The 5max ace catheter was used for a couple of passes; however, they physician removed the catheter and replaced it with a 4max catheter as he felt it wasn't working well.

Manufacturer Narrative

Conclusion: this device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Manufacturer Narrative

Result: the 5maxace reperfusion catheter is fractured approximately 1.0 cm from the hub.Conclusion: the complaint has been evaluated.The complaint indicates that the physician noted a "hole" near the hub of the 5maxace reperfusion catheter during use.The physician put a finger over the "hole" and attempted to use the catheter but decided to change to a different device because the 5maxace was not operating as expected.Evaluation of the returned device confirmed damage and a leak in the hypotube strain relief approximately 1.0 cm from the hub.This damage was likely due to handling when the device was manipulated during removal from the packaging or insertion into the patient.If the product is mishandled, damage to the catheter at the proximal strain relief may occur.Based on previous examinations of this complaint type, it has been determined that improper handling such as torquing or bending the proximal end of the catheter can cause this type of damage.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: 3737353
• MDR Text Key: 4223702
• Report Number: 3005168196-2014-00219
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F40743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2014
• 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
• Patient Age: 76 YR