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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 12/10/2021
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that an ultratome xl was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.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.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
(initial reporter facility name): (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that an ultratome xl was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.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.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Block e1 (initial reporter facility name): (b)(6).Block h6 (device codes): medical device problem 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, blackened, and bent/kinked, consistent with the findings when the device was observed under magnification.The working length was free from obvious kinks and bends.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, blackened, bent/kinked.The cutting wire being blackened indicates that the device was energized.Based on the condition of the device, the problem found could have been caused if the cutting wire was activated before use which may cause premature cutting wire fatigue and compromise the cutting wire's integrity.Not verifying that the cutting wire has exited the endoscope while electrical current is applied and not maintaining direct and constant contact with tissue when applying electrocautery current could also contribute to wire breakage.Also, excessive power may damage the integrity of cutting wire.The kinked cutting wire could have been generated if there was resistance felt at the cutting wire with the scope.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
 
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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 Key13231911
MDR Text Key284711592
Report Number3005099803-2022-00055
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 02/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/21/2023
Device Model NumberM00535900
Device Catalogue Number3590
Device Lot Number0027360698
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/21/2021
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 Age38 YR
Patient SexMale
Patient Weight72 KG
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