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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 07/01/2019
Event Type  malfunction  
Manufacturer Narrative
The exact date of the event is unknown.The provided event date (b)(6) 2019 was chosen as a best estimate based on the date that the manufacturer became aware of the event.The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.However, it was reported that the device was not used past expiry date.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
 
Event Description
Note: this report pertains to the first of two devices used during the same procedure.It was reported to boston scientific corporation that an ultratome xl was used in duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure.According to the complainant, during the procedure, after the cannulation and the guidewire was in the desired position, the physician attempted to perform sphincterotomy.When current was applied to the device, the cutting wire broke into half.The physician exchanged the device with a second ultratome xl; however, the cutting wire also broke into half.Reportedly, all connections were good and the generator was working fine prior to the activation.In addition, no part of the devices was 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 at the end of the procedure was reported to be fine.
 
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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 Key8826131
MDR Text Key153077610
Report Number3005099803-2019-03727
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729103318
UDI-Public08714729103318
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K930022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 07/25/2019
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 Model NumberM00535920
Device Catalogue Number3592
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/01/2019
Initial Date FDA Received07/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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