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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE FIXED WIRE; DILATOR, ESOPHAGEAL
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BOSTON SCIENTIFIC CORPORATION CRE FIXED WIRE; DILATOR, ESOPHAGEAL Back to Search Results
Model Number M00558360
Device Problem Burst Container or Vessel (1074)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/24/2019
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 gastrointestinal dilatation after endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon was attempted to be inflated; however, the balloon ruptured.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during a gastrointestinal dilatation after endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon was attempted to be inflated; however, the balloon ruptured.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: problem code 1074 captures the reportable issue of balloon burst.Block h10: investigation results a visual examination of the returned complaint device found that the balloon was burst.Based on the available information, it is possible that factors encountered during the procedure, such as lesion characteristics, handling of the device, and/or the technique used by the physician during the procedure, could have resulted in the reported failure.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
 
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Brand Name
CRE FIXED WIRE
Type of Device
DILATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key9612337
MDR Text Key189913312
Report Number3005099803-2019-06530
Device Sequence Number1
Product Code KNQ
UDI-Device Identifier08714729195986
UDI-Public08714729195986
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
Type of Report Initial,Followup
Report Date 03/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/01/2021
Device Model NumberM00558360
Device Catalogue Number5836
Device Lot Number0024360386
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2020
Date Manufacturer Received02/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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