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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRUETOME 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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BOSTON SCIENTIFIC CORPORATION TRUETOME 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00584180
Device Problems Break (1069); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/10/2023
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a truetome 44 was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During unpacking of the device, it was noticed that the cutting wire at the tip of the tome was misaligned.They attempted to straighten the wire by rotating the handle.After it was straightened, the physician decided to use the device into the patient; however, upon bowing the device, the cutting wire broke.It was reported that no part of the cutting wire detached and fell into the patient.The device was removed, and the procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.
 
Event Description
It was reported to boston scientific corporation that a truetome 44 was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During unpacking of the device, it was noticed that the cutting wire at the tip of the tome was misaligned.They attempted to straighten the wire by rotating the handle.After it was straightened, the physician decided to use the device into the patient; however, upon bowing the device, the cutting wire broke.It was reported that no part of the cutting wire detached and fell into the patient.The device was removed, and the procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.Block h10: the returned truetome 44 was analyzed, and a visual evaluation noted that the cutting wire was broken, kinked and blackened from the proximal pierce hole, which are consistent with the findings when the device was observed under magnification.The working length was also found twisted and the proximal pierce hole was torn.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, kinked and blackened.Based on the condition of the device, the problem found could have been generated if there was contact between the device and the scope during energization or if the generator exceeded the maximum of voltage during the procedure.Also, energizing the device prior to performing sphincterotomy can compromise the cutting wire's integrity and cause a premature cutting wire fatigue.Once the cutting wire breaks, any attempt to remove the device from the scope can lead to the broken section hitting the working channel of the scope.This can bend the cutting wire.It was also found that the working length was twisted which could have been caused after multiple attempts to rotate handle of the device or during the introduction of the device into the scope.Additionally, the working length was torn which could have been caused by submitting the cutting wire to tension during the handle actuation, or the possibility of the device being energized during the handle actuation.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.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
TRUETOME 44
Type of Device
UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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 Key18027061
MDR Text Key326806218
Report Number3005099803-2023-05789
Device Sequence Number1
Product Code KNS
UDI-Device Identifier08714729827641
UDI-Public08714729827641
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K122203
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00584180
Device Catalogue Number8418
Device Lot Number0031923607
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/29/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2023
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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