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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 M00535900
Device Problems Break (1069); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2023
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that an ultratome xl was used during an endoscopic sphincterotomy (est) procedure performed on (b)(6) 2023.During the procedure, when the handle was actuated, the cutting wire broke.The procedure was completed with another of the same device.There were no reported patient complications as a result of this event.Note: photos of the complaint device outside the patient were provided by the customer and showed the cutting wire was broken and kinked.
 
Manufacturer Narrative
Imdrf device code a0401 captures the reportable event of cutting wire broken.
 
Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.Block h10: the returned ultratome xl was analyzed, and a visual evaluation noted that the cutting wire was broken, and it was not returned.Per media analysis on the provided photo, the cutting wire was broken from the proximal pierced hole.Also, it was kinked.Additionally, the proximal end of the broken wire was blackened.These findings are consistent with the findings when the device was observed under magnification.Additionally, the distal pierced had remnants of cutting wire which suggests that the cutting wire was attached to the anchor.No other problems with the device were noted.The reported event of cutting wire break was confirmed.Upon analysis, it was found that the cutting wire was broken, and blackened.The cutting wire being blackened indicates that the device was energized.Based on the condition of the device, the problem found could have been generated if there was contact between the device and the scope during energization or if the generator exceeded the maximum of voltage during the procedure.Also, energizing the device prior to performing sphincterotomy can compromise the cutting wire's integrity and cause a premature cutting wire fatigue.Once the cutting wire breaks, any attempt to remove the device from the scope can lead to the broken section hitting the working channel of the scope.This can kink the cutting wire.It is most likely that procedural or anatomical factors encountered during the use of the device could have affected the device performance and its integrity.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
 
Event Description
It was reported to boston scientific corporation that an ultratome xl was used during an endoscopic sphincterotomy (est) procedure performed on (b)(6) 2023.During the procedure, when the handle was actuated, the cutting wire broke.The procedure was completed with another of the same device.There were no reported patient complications as a result of this event.Note: photos of the complaint device outside the patient were provided by the customer and showed the cutting wire was broken and kinked.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
2546 calle primera
alajuela
CS  
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key16625224
MDR Text Key312105773
Report Number3005099803-2023-01554
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729103257
UDI-Public08714729103257
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K930022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/08/2023
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 Date09/01/2024
Device Model NumberM00535900
Device Catalogue Number3590
Device Lot Number0030079690
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/07/2023
Initial Date FDA Received03/27/2023
Supplement Dates Manufacturer Received05/18/2023
Supplement Dates FDA Received06/08/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/02/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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