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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 M00558380
Device Problems Deflation Problem (1149); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/05/2018
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 stomach during an esophagogastroduodenoscopy (egd) with endoscopic ultrasound (eus) directed transgastric ercp (edge) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, it was noted that the catheter kinked while advancing down the scope but eventually was able to pass successfully.The procedure was continued and during deflation of the balloon, the water would not fully come out causing difficulty removing the device from the scope.Reportedly, the catheter was cut using tethers to removed the device from the scope.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
Problem code 1149 for the reportable issue of balloon failed to deflate.A visual examination of the returned complaint device revealed that several kinks was noted at the different sections of the catheter.The catheter was also noted to be mechanically cut near the balloon and the balloon was not returned with the device.Functional analysis was unable to be performed due to the condition of the device.It seems like the physician observed that the catheter of the device was kinked during the insertion; however, the device was used anyway.Also, it is most likely that resistance was met during the procedure due to the kinked catheter and excessive force was used when inserting the balloon, these events are advised against in the dfu.Therefore, the most probable root cause is unintended use error caused or contributed to event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
 
Event Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the stomach during an esophagogastroduodenoscopy (egd) with endoscopic ultrasound (eus) directed transgastric ercp (edge) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, it was noted that the catheter kinked while advancing down the scope but eventually was able to pass successfully.The procedure was continued and during deflation of the balloon, the water would not fully come out causing difficulty removing the device from the scope.Reportedly, the catheter was cut using tethers to removed the device from the scope.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.
 
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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 Key8206457
MDR Text Key131722823
Report Number3005099803-2018-62198
Device Sequence Number1
Product Code KNQ
UDI-Device Identifier08714729202011
UDI-Public08714729202011
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,health
Type of Report Initial,Followup
Report Date 02/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/02/2020
Device Model NumberM00558380
Device Catalogue Number5838
Device Lot Number0022597999
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2019
Date Manufacturer Received01/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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