MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRUETOME 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00584180

Device Problems Break (1069); Use of Device Problem (1670); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2021

Event Type  malfunction  

Manufacturer Narrative

(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 during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, the cutting wire of the truetome 44 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.

Event Description

It was reported to boston scientific corporation that a truetome 44 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, "the cutting wire position was not at the 11 o'clock position." the procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: additional information states that part of the cutting wire exited the endoscope when the device was energized; however, according to the instructions for use (ifu), verify that the cutting wire has exited the endoscope by visualizing it on the endoscope monitor.Not verifying that the cutting wire has exited the endoscope may result in contact between the cutting wire and the endoscope while electrical current is applied.This may cause grounding, which can result in patient injury, operator injury, a broken cutting wire, and/or damage to the endoscope.

Manufacturer Narrative

Block h2 additional information: block b5, h6 and h10 (device codes) have been updated based on additional information received on november 3, 2021.Block h6 (device codes): medical device problem code a1502 captures the reportable event of incorrect orientation of cutting wire.Block h10: the returned truetome 44 was analyzed, and a visual evaluation noted that the working length and the cutting wire did not have any visual problems/damages.A functional evaluation was performed by introducing the device into the scope using short and deliberate movements and it was noted that the initial orientation of the device was within specification when the distal tip was extended approximately 25mm past the elevator of the duodenoscope.No other problems with the device were noted.The reported event was not confirmed.The device did not have orientation problems.Upon analysis, it was found that the initial orientation of the device was within specification when the device was introduced into the scope.The working length and the cutting wire did not have any visual problems/damages.The unit returned did not show evidence of either the alleged problem or any defect that could have contributed to the event reported.Based on all gathered information, the most probable root cause of this complaint is no problem detected since the device complaint or problem cannot be confirmed.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 in a manner inconsistent with the instructions for use (ifu).Additional information states that part of the cutting wire exited the endoscope when the device was energized; however, according to the instructions for use (ifu), verify that the cutting wire has exited the endoscope by visualizing it on the endoscope monitor.Not verifying that the cutting wire has exited the endoscope may result in contact between the cutting wire and the endoscope while electrical current is applied.This may cause grounding, which can result in patient injury, operator injury, a broken cutting wire, and/or damage to the endoscope.

• 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 Key: 12532339
• MDR Text Key: 273318446
• Report Number: 3005099803-2021-04934
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729827641
• UDI-Public: 08714729827641
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K122203
• Number of Events Reported: 1
• 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: 11/24/2021

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 Date: 05/11/2023
• Device Model Number: M00584180
• Device Catalogue Number: 8418
• Device Lot Number: 0027291130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 09/27/2021
• Supplement Dates Manufacturer Received: 11/03/2021
• Supplement Dates FDA Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1