MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER; NRY

Catalog Number 3MAXC

Device Problems Break (1069); Defective Device (2588)

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

Event Date 12/09/2013

Event Type  malfunction  

Event Description

During the preparation for a thrombectomy procedure, the inventory specialist noted that the 3max reperfusion catheter was defective when it was removed from the box.The end was reportedly shredded.The device was never inside the patient and another catheter was used to complete the procedure.

Manufacturer Narrative

Result: the catheter appears to be fractured approximately 33.0 cm from the hub in proximal shaft.The break is in the middle of a material extrusion and not at a material bond.Conclusion: the device was returned for analysis and has been evaluated.The complaint indicates that the catheter was defective when it was remove from the box and noticed during preparation.Evaluation of the returned product confirmed that the catheter was fractured in the proximal shaft.Based on the description of the complaint, the cause of this damage could not be determined however, if the device is mishandled during removal from the packaging or preparation for use, damage such as this may occur.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA SYSTEM 3MAX 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 ; 5107483262
• MDR Report Key: 3568191
• MDR Text Key: 18857705
• Report Number: 3005168196-2014-00027
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113163
• 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: 12/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 3MAXC
• Device Lot Number: F38419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2013
• 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