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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 Consequences Or Impact To Patient (2199)
Event Date 10/01/2019
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
Note: this report pertains to the first of two ultratome xl devices used during the same procedure.It was reported to boston scientific corporation that an ultratome xl was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the ultratome was advanced through the scope to perform sphincterotomy.During the first attempt of electrocautery, the cutting wire broke.A second ultratome xl was used; however, the cutting wire broke after bowing the tome, prior to electrocautery.Reportedly, there was no part of the device detached inside the patient.The procedure was completed with a third ultratome xl, using the same generator and active cord.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be okay.
 
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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 DE COSTA RICA S.R.L.
2546 calle primera
propark, coyol,
alajuela
CS  
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key9235474
MDR Text Key178745777
Report Number3005099803-2019-05196
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729103318
UDI-Public08714729103318
Combination Product (y/n)N
Reporter Country CodeGR
PMA/PMN Number
K930022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 10/24/2019
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 Date06/05/2021
Device Model NumberM00535920
Device Catalogue Number3592
Device Lot Number0023910555
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/01/2019
Initial Date FDA Received10/24/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/06/2019
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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