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

Catalog Number 5MAXACE132

Device Problems Collapse (1099); Material Separation (1562)

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

Event Date 02/12/2014

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 reported that the catheter collapsed during aspiration.Upon retrieval, the catheter separated.The physician used another catheter to complete the procedure and there was no reported adverse effect on the patient.

Manufacturer Narrative

Result: the 5maxace catheter is fractured at approximately 19.0 and 20.0 cm from the hub.The 3max catheter is stuck inside of the fractured 5maxace catheter.The 5max catheter is flattened approximately 17.0 cm from the hub.The flat portion is approximately 95.0 cm in length.Conclusion: the device was returned for analysis and has been evaluated.The complaint indicates that the 5maxace collapsed under aspiration and then separated.The complaint did not describe any damage to the 3max or 5max catheters.A collapse in the catheter lumen was not confirmed however, evaluation of the returned product revealed two fractures in the 5maxace catheter.The 3max catheter was returned lodged inside of the fractured 5maxace.The 5max catheter was flattened beginning 17.0 cm from the hub moving distally for a length of 95.0 cm.The flattening in the 5max catheter may have been due to handling error if the rhv was not loosened prior to attempting to remove the catheter.These aspiration catheters are designed to withstand maximum aspiration pressure with the aspiration pump and do not collapse under aspiration.The cause of this complaint cannot directly be determined.The evaluation of the returned devices is not consistent with the description of the complaint.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This mdr is associated with mdr 3005168196-2014-00183 and 00184.

• 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: 3691325
• MDR Text Key: 4256991
• Report Number: 3005168196-2014-00178
• 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: Health Professional
• Type of Report: Initial
• Report Date: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F36594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2013
• 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