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

Catalog Number 5MAXACE132

Device Problems Kinked (1339); Improper or Incorrect Procedure or Method (2017)

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

Event Date 05/07/2014

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system 5max ace reperfusion catheter.During the procedure, the physician tightened the rotating hemostatic valve (rhv) too tight and caused the 5max ace reperfusion catheter to kink.There was no report of an adverse effect on the patient and the procedure was completed using a different catheter.

Manufacturer Narrative

Result: the 5maxace catheter is kinked approximately 8.5 cm and 10.5 cm from the distal tip.Conclusion: the complaint has been evaluated.The complaint indicates that the 5maxace catheter was kinked by tightening the rhv onto the catheter too tight.Evaluation of the returned device confirmed two kinks in the catheter shaft.The observed damage is consistent with over tightening the rhv on the catheter during use.These devices are 100% visually inspected for damage during packaging.

• 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: 3885101
• MDR Text Key: 18925974
• Report Number: 3005168196-2014-00407
• 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
• Report Date: 05/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• 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: 06/09/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2014
• 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