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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK CRE? WIREGUIDED; DILATOR, ESOPHAGEAL
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BOSTON SCIENTIFIC - CORK CRE? WIREGUIDED; DILATOR, ESOPHAGEAL Back to Search Results
Model Number M00558500
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/20/2014
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used during a gastroscopy balloon dilatation procedure in the esophagus performed on (b)(6) 2014.According to the complainant, during insertion, the physician was unable to push the device down the biopsy channel.After removal, the device was inspected and it was noted that there was gathering of the exit marker.The procedure was completed with another cre balloon.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
A visual examination of the complaint device revealed that the exit marker was loose.The visual inspection also revealed that the catheter had a kink.A functional examination was not performed because the balloon was relaxed and deflated, which made the device unable to be inserted into a scope.Based on the condition of the returned device, the reported failure of exit marker loose was confirmed.This failure likely occurred because a vacuum was not maintained during insertion through the scope.It is likely that excessive force was used to overcome the resistance experienced during device advancement through the scope, which resulted in the exit marker becoming loose and the catheter to become kinked.The directions for use (dfu) requires that a vacuum is applied to the balloon to maximize endoscopic passage of the balloon through the scope.Therefore, the most probably root cause is user/use error.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A search of the complaint database revealed that no other complaints exist for the specified lot.
 
Event Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used during a gastroscopy balloon dilatation procedure in the esophagus performed on (b)(6) 2014.According to the complainant, during insertion, the physician was unable to push the device down the biopsy channel.After removal, the device was inspected and it was noted that there was gathering of the exit marker.The procedure was completed with another cre balloon.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Reported event of exit marker loose/detached.Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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.
 
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Brand Name
CRE? WIREGUIDED
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 Key4302858
MDR Text Key5173056
Report Number3005099803-2014-03708
Device Sequence Number1
Product Code KNQ
Combination Product (y/n)N
Reporter Country CodeZA
PMA/PMN Number
K110833
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2016
Device Model NumberM00558500
Device Catalogue Number5850
Device Lot Number15869988
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/04/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/18/2013
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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