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

Catalog Number 5MAXACE132

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2014

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system 5max ace reperfusion catheter.During the procedure, a hole was noticed in the catheter.The physician attempted to occlude the hole; however, was unsuccessful.A new 5max ace was used to complete the procedure.There was no report of an adverse effect on the patient.

Manufacturer Narrative

Result: the penumbra reperfusion catheter 5max ace was returned with tape and plastic wrapped around the strain relief covering the damage.The catheter was kinked approximately 2.5 cm from the hub.Conclusion: the complaint has been evaluated.The complaint indicated that the penumbra reperfusion catheter 5max ace had a hole near the hub.Evaluation of the returned device confirmed a kink in the shaft of the catheter underneath the strain relief.This type of damage typically occurs when the product is improperly handled during removal from the packaging hoop.If the product is removed at angle while force is being applied, it is likely that damage will occur.These 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: 4393928
• MDR Text Key: 5434716
• Report Number: 3005168196-2015-00001
• 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: Radiologic Technologist
• Type of Report: Initial
• Report Date: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F36266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2013
• 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
• Patient Age: 66 YR