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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CRE¿ WIREGUIDED DILATOR, ESOPHAGEAL

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CRE¿ WIREGUIDED DILATOR, ESOPHAGEAL Back to Search Results
Model Number M00558420
Device Problems Balloon; Burst Container or Vessel ; Hole In Material
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.

 
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Brand NameCRE¿ WIREGUIDED
Type of DeviceDILATOR, ESOPHAGEAL
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough , MA 01752
5086834000
MDR Report Key6980449
Report Number3005099803-2017-03247
Device Sequence Number1
Product CodeKNQ
Report Source Manufacturer
Type of Report Initial
Report Date 10/01/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/26/2017
Device Operator NO INFORMATION
Device MODEL NumberM00558420
Device Catalogue Number5842
Was Device Available For Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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