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

Model Number M00584170

Device Problems Failure to Fold (1255); Failure to Align (2522)

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

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

(device codes): imdrf device code a050701 captures the reportable event of cutting wire unable to release bow (unbow).

Event Description

It was reported to boston scientific corporation that a truetome 44 was used in the sphincter of oddi during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.At the beginning of the procedure, the device was unable to bow.During the procedure, it was noticed that the wire stayed bowed, and did not unbow.It was also noticed that the device bowed out of plane and then at the end, the device did not bow at all.The procedure was completed with another truetome 44.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

Event Description

It was reported to boston scientific corporation that a truetome 44 was used in the sphincter of oddi during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.At the beginning of the procedure, the device was unable to bow.During the procedure, it was noticed that the wire stayed bowed, and did not unbow.It was also noticed that the device bowed out of plane and then at the end, the device did not bow at all.The procedure was completed with another truetome 44.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block h6 (device codes): imdrf device code a050701 captures the reportable event of cutting wire unable to release bow (unbow).Block h10: the returned truetome 44 was analyzed, and a visual evaluation noted that the cutting wire was kinked.A functional evaluation noted that the device was able to bow and returned from bowed position as intended when the bow test was performed outside and inside the scope.When the handle was actuated, the distal tip bowed in front of the camera of the duodenoscope.Also, the catheter was correctly oriented 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 of wire unable to release bow (unbow) was not confirmed.Upon analysis, the device bowed and returned from the bow as intended, and it bowed in front of the camera of the duodenoscope when the handle was actuated.It was observed that the cutting wire was kinked.Based on the condition of the device, the problem found could have been generated due to handling and manipulation of the device during procedure and interaction with the scope/guidewire and additional tools/devices.It is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance and integrity.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.

• 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: 16428198
• MDR Text Key: 310254658
• Report Number: 3005099803-2023-00897
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729827634
• UDI-Public: 08714729827634
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00584170
• Device Catalogue Number: 8417
• Device Lot Number: 0029934811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2022
• 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
• Patient Age: 21 YR
• Patient Sex: Male
• Patient Race: White