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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK CRE¿ FIXED WIRE; DILATOR, ESOPHAGEAL
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BOSTON SCIENTIFIC - CORK CRE¿ FIXED WIRE; DILATOR, ESOPHAGEAL Back to Search Results
Model Number M00558350
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/11/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during a balloon dilation procedure performed on (b)(6) 2017.According to the complainant, the balloon was inflated outside of the patient, and it was noted that the balloon was twisted.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.Attempts to obtain additional patient and procedure information have been unsuccessful.If any further relevant information is received, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during a balloon dilation procedure performed on (b)(6) 2017.According to the complainant, the balloon was inflated outside of the patient, and it was noted that the balloon was twisted.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.Attempts to obtain additional patient and procedure information have been unsuccessful.If any further relevant information is received, a supplemental mdr will be filed.Correction information received on 27nov2017.The balloon was not inflated outside of the patient prior to the procedure; only a visual check was performed before use, which is when the balloon was found to be twisted.
 
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Brand Name
CRE¿ FIXED WIRE
Type of Device
DILATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI 
Manufacturer (Section G)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI  
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key7003188
MDR Text Key92074731
Report Number3005099803-2017-03404
Device Sequence Number1
Product Code KNQ
Combination Product (y/n)N
PMA/PMN Number
K971320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 10/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2019
Device Model NumberM00558350
Device Catalogue Number5835
Device Lot Number20490881
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/07/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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