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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 Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/21/2023
Event Type  malfunction  
Manufacturer Narrative
Imdrf device code (b)(4) captures the reportable event of cutting wire break.
 
Event Description
It was reported to boston scientific corporation that an ultratome xl was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, when the sphincter was cut, "the wire was fractured." the procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.No further information has been obtained despite good faith efforts.The reported event may suggest that the cutting wire broke.
 
Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.Block h2 (additional information): block e1 (initial reporter address 1 and address 2, city and zip/postal code) have been updated based on the additional information received on march 20, 2023.
 
Event Description
It was reported to boston scientific corporation that an ultratome xl was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, when the sphincter was cut, "the wire was fractured." the procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.No further information has been obtained despite good faith efforts.The reported event may suggest that the cutting wire broke.
 
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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 Key16569633
MDR Text Key311745635
Report Number3005099803-2023-01304
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729103257
UDI-Public08714729103257
Combination Product (y/n)N
Reporter Country CodeCH
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 04/11/2023
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 Date03/15/2024
Device Model NumberM00535900
Device Catalogue Number3590
Device Lot Number0029057695
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/21/2023
Initial Date FDA Received03/18/2023
Supplement Dates Manufacturer Received03/20/2023
Supplement Dates FDA Received04/11/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/16/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age87 YR
Patient SexMale
Patient Weight56 KG
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