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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 Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/28/2023
Event Type  malfunction  
Manufacturer Narrative
Imdrf device code a0401 captures the reportable event of cutting wire broken.
 
Event Description
It was reported to boston scientific corporation that an ultratome xl was used before the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the cutting wire of the ultratome xl broke.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
 
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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 Key16503722
MDR Text Key311332143
Report Number3005099803-2023-01243
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729103318
UDI-Public08714729103318
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K930022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 03/08/2023
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 Model NumberM00535920
Device Catalogue Number3592
Device Lot Number0030419631
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/28/2023
Initial Date FDA Received03/08/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/25/2022
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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