MAUDE Adverse Event Report: CRE¿ WIREGUIDED; DILATOR, ESOPHAGEAL

Model Number M00558420

Device Problems Burst Container or Vessel (1074); Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the 39 events reported under exemption number e2012013, 32 complaint devices were returned, 6 complaint devices were disposed, and 1 complaint device was not returned.Thirteen events were found to have a root cause of operational context, 1 event was found to have a root cause of handling, 14 events were found to have a root cause of supplier design, and 1 event was found to have a root cause of user error.Investigation is still in place for 3 events.

Event Description

The manufacturer report is being sent as a requirement under summary reporting exemption approval number - e2012013 for product code knq.This report covers 39 reported events of balloons bursts/pinholes.Of the events, 1 patient was female and 10 were male.The known patients' ages ranged from 32 years to 81 years.The known patients' weights ranged from 58 kg to 68 kg.All other demographic information is unknown.

• Brand Name: CRE¿ WIREGUIDED
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6980449
• MDR Text Key: 91188833
• Report Number: 3005099803-2017-03247
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• PMA/PMN Number: K110833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Device Operator: No Information
• Device Model Number: M00558420
• Device Catalogue Number: 5842
• Type of Device Usage: N
• Patient Sequence Number: 1