MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION PNEUMOSTAT CHEST VALVE; BOTTLE, COLLECTION, VACUUM

Device Problems Obstruction of Flow (2423); Device Dislodged or Dislocated (2923); Gas/Air Leak (2946)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

We are unable to fully investigate this report as no product number, lot number or sample was provided.It is not known what relationship the pneumostat chest valve has to the reported adverse events.The article suggests that outpatient management of selected patients with ssp may be effective, safe and cost-saving.Based on the information available atrium has determined that the events described are not related to a product failure.Not available for return.

Event Description

Received an article titled safety and efficacy of ambulatory management of secondary spontaneous pneumothorax: a case series.Purpose: we prospectively evaluated our practice over a 3-year period and explore outcomes of patients with ssp using primary spontaneous pneumothorax (psp) as a comparator group.Method: 163 consecutive patients presenting to our hospital between september 2014 and july 2017 were evaluated using a predefined protocol.Per the article adverse events included: persistent air leak requiring surgery, drain dislodgement, blockage, empyema, pain, recurrence.

• Brand Name: PNEUMOSTAT CHEST VALVE
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: lynda mclaughlin ; 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 10000773
• MDR Text Key: 190436694
• Report Number: 3011175548-2020-00582
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/27/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2020
• Initial Date FDA Received: 04/27/2020
• Was Device Evaluated by Manufacturer?: No
• 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