MAUDE Adverse Event Report: CRE¿ PULMONARY; BRONCHOSCOPE ACCESSORY

Model Number M00550350

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the 4 events reported under exemption number e2012010, 3 complaint devices were returned, and 1 complaint device was disposed.1 event was found to have a root cause of operational context, and 1 event was found to have a root cause of handling.Investigation is still in place for 1 event.

Event Description

The manufacturer report is being sent as a requirement under summary reporting exemption approval number e2012010 for product code kti.This report covers 4 reported events of balloons hole/leak/tears.Of the events, 2 patients were female and 1 was male.The known patients' ages ranged from 55 years to 68 years.The known patients' weights ranged from 43 kg to 70 kg.All other demographic information is unknown.

• Brand Name: CRE¿ PULMONARY
• Type of Device: BRONCHOSCOPE ACCESSORY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7464191
• MDR Text Key: 106839743
• Report Number: 3005099803-2018-01402
• Device Sequence Number: 1
• Product Code: KTI
• Combination Product (y/n): N
• PMA/PMN Number: K023337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 03/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Device Operator: No Information
• Device Model Number: M00550350
• Device Catalogue Number: 5035
• Type of Device Usage: N
• Patient Sequence Number: 1