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

Catalog Number 5MAXACE132

Device Problems Break (1069); Suction Problem (2170)

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

Event Date 11/09/2014

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure in the left middle cerebral artery using a penumbra system max aspiration tubing, penumbra system 5max ace reperfusion catheters, and penumbra system non-sterile pump max supplies.During the procedure, the physician turned on the pump and there was no suction through the max aspiration tubing, the 5max ace reperfusion catheter, and the non-sterile pump max supplies.These products were exchanged and the procedure continued using other products.While attempting to advance another manufacturer's catheter through a new 5max ace reperfusion catheter, the physician found a break in the 5max ace.The 5max ace was removed and the procedure successfully continued using new devices.There was no report of an adverse effect on the patient.

Manufacturer Narrative

Conclusion: the device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This mdr is associated with mdr 3005168196-2014-00872, 00873, and 00874.

Manufacturer Narrative

Result: the 5max ace was fractured approximately 33.0 cm from the hub in the middle of the polymer material of the catheter shaft.The break showed evidence of material deformation and stretching.Conclusion: the complaint has been evaluated.The complaint indicated that while using a 5maxace, aspiration tubing, aspiration pump, and a canister, no suction was delivered to through the system.In addition, the complaint described that a second 5max ace ruptured in the proximal shaft when used with a non-penumbra microcatheter.Evaluation of the returned aspiration tubing (pst2) revealed no visible damage.The tubing was tested and was fully functional.No device issue could be confirmed.The other devices used with the tubing were not returned for evaluation therefore, the cause of the issue could not be determined.Evaluation of the returned 5max ace confirmed a fracture in the proximal shaft.This type of damage typically occurs due to improper handling during use.If the 5max ace is manipulated at an angle while force is being applied, damage such as this may occur.According to dimensions listed on the non-penumbra product's website, the microcatheter described in the complaint should have been compatible with the 5max ace.Penumbra devices are 100% visually inspected for damage during process inspection.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: 4338812
• MDR Text Key: 5203360
• Report Number: 3005168196-2014-00875
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K090752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/19/2014

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 Expiration Date: 08/31/2017
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F45354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2015
• Initial Date FDA Received: 12/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2014
• 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