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

Catalog Number 5MAXACE132

Device Problems Detachment Of Device Component (1104); Hole In Material (1293); Failure to Advance (2524)

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

Event Date 09/25/2015

Event Type  malfunction  

Manufacturer Narrative

Results: the penumbra system 5max ace reperfusion catheter (5max ace) was ovalized approximately 128.0 cm from the hub and fractured approximately 133.0 cm from the hub.The distal tip of the 5max ace was ovalized.The effective length of the 5max ace was measured and found to be within specification.Conclusions: evaluation of the returned device confirmed the distal shaft was fractured and the distal tip was ovalized.This type of damage typically occurs due to improper handling during use.If the 5max ace is manipulated forcefully against resistance during advancement or retraction, damage such as this may occur.Additionally, if the 5max ace is roughly handled or held too close to the heat source during steam shaping, the catheter shaft may become more vulnerable to damage.If the catheter is ovalized or improperly steam-shaped, the catheter lumen may become compromised.These devices are 100% visually evaluated during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a thrombectomy procedure for a venous sinus thrombosis using a penumbra system 5max ace reperfusion catheter (5max ace).During the procedure, the 5max ace was inserted through another manufacturer's guide catheter.The physician then advanced two other manufacturer's devices through the 5max ace.However, one of the devices came out from an unexpected part of the 5max ace and not from the distal tip.The physician was unable to advance the devices any further and removed the 5max ace.Upon inspection of the 5max ace, the physician confirmed a hole on the side of the 5max ace tip and also noticed that the 5max ace was fractured.The physician attempted to use another manufacturer's stent retriever for the remainder of the procedure but was unsuccessful and the procedure was stopped.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5234453
• MDR Text Key: 31708915
• Report Number: 3005168196-2015-01159
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012803
• UDI-Public: 00814548012803
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F64774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2015
• 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: 46 YR
• Patient Weight: 50