MAUDE Adverse Event Report: CRE¿ PULMONARY; BRONCHOSCOPE ACCESSORY

Model Number M00550350

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the 3 events reported under exemption number e2012010, 1 complaint device was returned and 2 complaint devices were not returned.One event was found to have a root cause of supplier design.Conclusion code 4316 is being used in lieu of an adequate conclusion code for "device not returned" for all relevant events.

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 3 reported events of balloons leaks/pinholes.Of the events, 1 patient was female.One patient's age was (b)(6).One patient's weight was (b)(6).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: 7732637
• MDR Text Key: 115582059
• Report Number: 3005099803-2018-02482
• 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: 07/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: No Information
• Device Model Number: M00550350
• Device Catalogue Number: 5035
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/30/2018
• Type of Device Usage: N
• Patient Sequence Number: 1