MAUDE Adverse Event Report: UPTAKE MEDICAL CORP. INTERVAOR SYSTEM, CATHETER; INTERVAPOR SYSTEM CATHETER

Model Number UM-CTH-100

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

Patient Problems Death (1802); Pulmonary Emphysema (1832); Pneumonia (2011); Respiratory Distress (2045); Sepsis (2067); Weight Changes (2607)

Event Date 02/08/2012

Event Type  Death  

Event Description

Report pt death 19 days post intervapor therapy.Post therapy, the pt's functions continued to decline and she developed massive nosocomial pneumonia involving the entire left hemithorax with pronounced consolidation in the left mid-lung field.Referral physicians considered and declined lung transplantation due to the pt's severe hypercapnic respiratory failure and sepsis.Pt trended toward cachexia with a bmi of (b)(6).Pt had profound severe emphysema with prior hypercapnic issues and demonstrated decline in function from (b)(6) 2011 to (b)(6) 2012.Her death culminated in a choice to not resuscitate following a 15 year history of severe emphysema.Pt expired due to nosocomial pneumonia.Pt had severe gold stage iv emphysema with fev1 <20 <15.Comorbidity history included: prothrombin mutation; apoplexy; stroke; herniated disc with neuro implants (4) for pain.

Manufacturer Narrative

This mdr is being reported retrospectively.However, a report was filed with (b)(4) on (b)(4) 2012 (b)(4) as the product was marketed in europe.(b)(4).

• Brand Name: INTERVAOR SYSTEM, CATHETER
• Type of Device: INTERVAPOR SYSTEM CATHETER
• Manufacturer (Section D): UPTAKE MEDICAL CORP.; tustin CA
• Manufacturer Contact: 1173 warner ave; tustin, CA 92780 ; 9494911377
• MDR Report Key: 4039932
• MDR Text Key: 4904249
• Report Number: 3009385324-2014-00002
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2012
• Device Model Number: UM-CTH-100
• Device Lot Number: B2455740A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2012
• Initial Date FDA Received: 08/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2011
• 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
• Treatment: THYROID HORMONE REPLACEMENT.; FOUR NEURO IMPLANTS FOR INTERVERTEBRAL DISC; INJURY. TREATED FOR HIGH CHOLESTEROL AND
• Patient Outcome(s): Death
• Patient Age: 44 YR
• Patient Weight: 63