MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 60 HI-FLOW KIT; NRY

Catalog Number 5MAXACE132KIT-A

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2016

Event Type  malfunction  

Manufacturer Narrative

Results: the penumbra system ace 60 reperfusion catheter (ace 60) was stretched from approximately 109.0 cm from the hub.The stretched segment was approximately 14.0 cm long.Conclusions: evaluation of the returned ace 60 revealed it was stretched.It is possible for the distal segment of the ace 60 to become restrained against patient anatomy or other devices used in the procedure that may have prolapsed in the patient anatomy.If the distal segment of ace 60 is pinned or otherwise restrained, and then forcefully withdrawn against the resistance, the catheter shaft may become stretched.The neuron max mentioned in the complaint was not returned for evaluation.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.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 using a penumbra system ace 60 reperfusion catheter (ace 60) kit.During the procedure, the physician advanced the ace 60 through a neuron max 088(neuron max) and started aspiration.However, while using the ace 60 during the first pass, the physician noticed that flow was not established and therefore the ace 60 was slowly removed.However, upon removing the ace 60, the physician noticed it was flattened near the distal tip.The physician then achieved partial reperfusion of the target vessel using a new ace 60 with the same neuron max and the procedure was completed at this point.There was no report of an adverse effect on the patient.

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system ace 60 reperfusion catheter (ace 60) kit.During the procedure, the physician advanced the ace 60 through a neuron max 088 (neuron max) and started aspiration.However, while using the ace 60 during the first pass, the physician noticed that flow was not established and therefore the ace 60 was slowly removed.However, upon removing the ace 60, the physician noticed it was flattened near the distal tip.The physician then achieved partial reperfusion of the target vessel using a new ace 60 with the same neuron max and the procedure was completed at this point.There was no report of an adverse effect on the patient.

• Brand Name: PENUMBRA SYSTEM ACE 60 HI-FLOW KIT
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5929387
• MDR Text Key: 53948591
• Report Number: 3005168196-2016-01270
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548017433
• UDI-Public: 00814548017433
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/21/2018
• Device Catalogue Number: 5MAXACE132KIT-A
• Device Lot Number: F67957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2015
• 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: 31 YR
• Patient Weight: 113