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

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2018

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.The hospital discarded the device.

Event Description

The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) using an ace catheter.During the procedure, the physician advanced a filter wire into the patient¿s ica, and then advanced the ace catheter past the filter wire, using a neuron max 6f 088 long sheath (neuron max).While in the patient, the radiopaque marker on the ace catheter broke off and was floating in the middle cerebral artery (mca).The physician therefore removed the radiopaque marker using a non-penumbra stent retriever.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM ACE REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7553707
• MDR Text Key: 109544707
• Report Number: 3005168196-2018-01075
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention