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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 M00584170
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2022
Event Type  malfunction  
Manufacturer Narrative
Initial reporter email: (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 a truetome 44 was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the cutting wire of the truetome 44 was broken.It was reported that no part of the cutting wire detached and fell into the patient.The device was removed outside the patient and the procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that a truetome 44 was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the cutting wire of the truetome 44 was broken.It was reported that no part of the cutting wire detached and fell into the patient.The device was removed outside the patient 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 e1 (initial reporter email): (b)(6).Block h6 (device codes): medical device problem 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 and bent from the proximal pierced hole, which are consistent with the findings when the device was observed under magnification.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.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 kink the cutting wire.It is most likely that procedural or anatomical factors encountered during the use of the device could have affected the device performance and its integrity.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
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 Key14643508
MDR Text Key295504046
Report Number3005099803-2022-03047
Device Sequence Number1
Product Code KNS
UDI-Device Identifier08714729827634
UDI-Public08714729827634
Combination Product (y/n)N
Reporter Country CodeGM
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 07/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/16/2023
Device Model NumberM00584170
Device Catalogue Number8417
Device Lot Number0028398454
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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