MAUDE Adverse Event Report: PNEUMBRA, INC. PNEUMBRA; 5 MAX ACE SEPERATOR, 3 MAX ACE SEPERATOR, 6F SELECT CATHETER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Headache (1880); Necrosis (1971); Weakness (2145); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 01/18/2016

Event Type  Injury  

Event Description

Patient was hospitalized (b)(6) 2016 with increasing headache and increasing weakness.She had recent ct and mri of the brain which revealed edema with possible mass or possible infectious cause.Patient was taken to the operating room on (b)(6) 2016 for open tumor biopsy in the right temporoparietal region.Pathology was sent to (b)(6) and findings were returned to (b)(6) on (b)(6) 2016.Biopsy shows a presence of areas of necrosis associated with a dense polymorphonuclear cell infiltrate surrounded by a histiocystic granulomatous reaction with presence of giant cells.In one of the granulomatous, fukanebtiys granular pale blue foreign body material is identified consistent with fragments of catheter hydrophilic polymer coating.The inflammatory process appears to involve the leptomeninges as well as the underlying brain parenchyma.The presumed origin for the material would be the coating on the devices used for her mechanical thrombectomy on (b)(6) 2015.In review of literature, this appears to be a rare but reported potential complication (am j surg pathol.2008; 32: 1310-1316).

• Brand Name: PNEUMBRA
• Type of Device: 5 MAX ACE SEPERATOR, 3 MAX ACE SEPERATOR, 6F SELECT CATHETER
• Manufacturer (Section D): PNEUMBRA, INC. ; one pneumbra place; alameda CA 94502
• MDR Report Key: 5419710
• MDR Text Key: 37960597
• Report Number: MW5060059
• Device Sequence Number: 1
• Product Code: HCG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 62