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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 M00558370
Device Problems Deflation Problem (1149); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/30/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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.
 
Event Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during an upper endoscopy procedure performed on (b)(6) 2019.According to the complainant, upon opening the package the balloon was noted to be twisted.Reportedly, the balloon was still used during the procedure; however, the balloon could not be deflated.They had to pull the scope out of the patient in order for the balloon to be removed.The procedure was completed at this time.There have been no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.
 
Event Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during an upper endoscopy procedure performed on (b)(6) 2019.According to the complainant, upon opening the package the balloon was noted to be twisted.Reportedly, the balloon was still used during the procedure; however, the balloon could not be deflated.They had to pull the scope out of the patient in order for the balloon to be removed.The procedure was completed at this time.There have been no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.
 
Manufacturer Narrative
Problem code 1149 captures the reportable event of balloon failed to deflate.Problem code 2976 captures the reportable event of balloon twisted.Investigation results a visual examination of the returned complaint device found that the catheter was kinked in different sections and was noticed to be mechanically cut near the balloon.It was also noted that the balloon was not returned.Dimensional examination of the outer diameter of the catheter was performed and was measured in three sections; distal, medium and proximal.The measurements were found to be within specifications.This failure is likely due to factors encountered during the procedure, such as the manner the device was handled and/or interaction with the scope, that could have affected its performance and its intended purpose.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 Key9371444
MDR Text Key187064225
Report Number3005099803-2019-05611
Device Sequence Number1
Product Code KNQ
UDI-Device Identifier08714729195993
UDI-Public08714729195993
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 12/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/14/2021
Device Model NumberM00558370
Device Catalogue Number5837
Device Lot Number0023190061
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2019
Date Manufacturer Received12/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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