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

Model Number M00584170

Device Problem Positioning Problem (3009)

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

Event Date 01/08/2022

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 in the common bile duct during an endoscopic sphincterotomy (est) procedure performed on (b)(6) 2022.During the procedure, it was noticed that the direction of the cutting wire was not fixed and was continuously changing.It was reported that the direction of the cutting wire not correct when the device exited the scope.There was no any visible damage to the device prior to putting it through the scope and after the issue occurred.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 ok.

Event Description

It was reported to boston scientific corporation that a truetome 44 was used in the common bile duct during an endoscopic sphincterotomy (est) procedure performed on (b)(6) , 2022.During the procedure, it was noticed that the direction of the cutting wire was not fixed and was continuously changing.It was reported that the direction of the cutting wire not correct when the device exited the scope.There was no any visible damage to the device prior to putting it through the scope and after the issue occurred.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 ok.

Manufacturer Narrative

Block h6 (device codes): medical device problem code a1502 captures the reportable event of incorrect cutting wire orientation.Block h10: the returned truetome 44 was analyzed, and a visual evaluation noted that the working length was twisted.The device was observed under magnification and the tip was twisted.A functional evaluation was performed by inserting the device into the scope, and when the distal tip was extended approximately 25mm past the elevator of the duodenoscope, it was noticed that the catheter was not in the correct orientation due to the twist.No other problems with the device were noted.The reported event of incorrect wire orientation was confirmed.Upon analysis, it was found that the working length was twisted, affecting the wire orientation of the device.Based on the condition of the device, it could have been generated due to multiple attempts of rotating the device or during introduction of the device into 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.

• 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: 13361290
• MDR Text Key: 289896702
• Report Number: 3005099803-2022-00218
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729827634
• UDI-Public: 08714729827634
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2023
• Device Model Number: M00584170
• Device Catalogue Number: 8417
• Device Lot Number: 0026786814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2021
• 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