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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRATOME XL; SNARE, FLEXIBLE
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BOSTON SCIENTIFIC CORPORATION ULTRATOME XL; SNARE, FLEXIBLE Back to Search Results
Model Number M00535920
Device Problem Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/19/2018
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 an ultratome xl was used in the duodenum during a stone removal procedure performed on (b)(6) 2018.According to the complainant, during the procedure, with the scope elevator in neutral position, it was noticed that the cutwire was oriented in the wrong direction.Reportedly, there was no tortuous anatomy or other procedural factors impacting cope positioning and no visible damage to the device prior to putting it through the scope or after the issue occurred.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the end of the procedure was reported to be stable.
 
Manufacturer Narrative
(b)(4).Block h10: visual examination of the returned device revealed that the working length was twisted at the distal section.Functionally, the device was introduced inside the duodenoscope and the initial tip orientation was found out of specification due to the condition of the working length (twisted).The complaint was consistent with the reported event of incorrect wire orientation.It is most likely that the failure found (working length twisted) is an issue that could have been generated by the user or due to the interacting of the device with the other devices used in the same procedure, and it is most likely that due to procedural factors encountered during the procedure the performance of the product was limited.Therefore, the most probable cause of this complaint is adverse event related to procedure since it is most likely that due to procedural factors encountered during the procedure the performance of the product was limited.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release to distribution.
 
Event Description
It was reported to boston scientific corporation that an ultratome xl was used in the duodenum during a stone removal procedure performed on (b)(6) 2018.According to the complainant, during the procedure, with the scope elevator in neutral position, it was noticed that the cutwire was oriented in the wrong direction.Reportedly, there was no tortuous anatomy or other procedural factors impacting cope positioning and no visible damage to the device prior to putting it through the scope or after the issue occurred.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the end of the procedure was reported to be stable.
 
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Brand Name
ULTRATOME XL
Type of Device
SNARE, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8250985
MDR Text Key133201746
Report Number3005099803-2019-00088
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729103318
UDI-Public08714729103318
Combination Product (y/n)N
PMA/PMN Number
K930022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/25/2020
Device Model NumberM00535920
Device Catalogue Number3592
Device Lot Number0022304188
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2019
Initial Date Manufacturer Received 12/19/2018
Initial Date FDA Received01/15/2019
Supplement Dates Manufacturer Received02/11/2019
Supplement Dates FDA Received03/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age43 YR
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