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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); Inflation Problem (1310); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/27/2020
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 an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noted that there was difficulty inflating and deflating the balloon.Additionally, it was also noticed that the catheter was twisted that might have contributed to the issue.The device was then pulled out from the patient and cut from the scope.The procedure was completed at this time.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 an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noted that there was difficulty inflating and deflating the balloon.Additionally, it was also noticed that the catheter was twisted that might have contributed to the issue.The device was then pulled out from the patient and cut from the scope.The procedure was completed at this time.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: problem code 1149 captures the reportable event of balloon failed to deflate.Visual examination of the returned complaint device found that only the distal part of the device was received, and the balloon was found to be twisted.A microscopic examination of the device found that the catheter had been cut, which is consistent with what the customer reported.Functional evaluation could not be performed due to the condition of the device, and therefore the reported problem of deflation failure cannot be confirmed.It is possible that factors encountered during the procedure, the interaction with the scope, prolonged procedure, and/or the technique used by the physician during the insertion could have caused the twist in the balloon and, for this reason, was difficult to inflate and deflate.Also, this twist in the balloon could have caused the physician to feel some resistance when being pulled out from the patient, resulting in the physician needing to cut the catheter for removal.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.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.
 
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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 Key10899895
MDR Text Key226371658
Report Number3005099803-2020-05571
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 12/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/20/2022
Device Model NumberM00558380
Device Catalogue Number5838
Device Lot Number0025739214
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2020
Date Manufacturer Received12/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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