MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRUETOME 49; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00584160

Device Problems Break (1069); Material Deformation (2976)

Patient Problem Twitching (2172)

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon 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 (bsc) that a truetome 49 was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, when the physician pressed the foot switch to perform sphincterotomy, it was noticed that the patient's muscle was twitching and the cutting wire of the truetome 49 broke.It was reported that no part of the cutting wire detached and fell into the patient.Additionally, there was no treatment or intervention performed to address the patient's muscle twitching.The physician removed the device and the procedure was completed with a non bsc 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 stable.Note: a photo of the complaint device outside the patient was provided by the customer and showed the wire was broken and kinked.

Event Description

It was reported to boston scientific corporation (bsc) that a truetome 49 was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, when the physician pressed the foot switch to perform sphincterotomy, it was noticed that the patient's muscle was twitching and the cutting wire of the truetome 49 broke.It was reported that no part of the cutting wire detached and fell into the patient.Additionally, there was no treatment or intervention performed to address the patient's muscle twitching.The physician removed the device and the procedure was completed with a non bsc 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 stable.Note: a photo of the complaint device outside the patient was provided by the customer and showed the wire was broken and kinked.

Manufacturer Narrative

Block h6 (device codes): medical device problem code a0401 captures the reportable event of cutting wire broken.Block h10: the returned truetome 49 was analyzed, and a visual evaluation noted that the cutting wire was broken, blackened, and kinked.Additionally, jammed marks were observed on device body.These findings were consistent when the device was observed under magnification.A functional evaluation was not performed due to the condition of the device.Per media analysis, the picture shows that the exposed cutting wire was broken and kinked.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, blackened, and kinked.The cutting wire being blackened indicates that the device was energized.Based on the condition of the device, the problem found could have been caused if the device was operated during a prolonged process and/or if it was also in contact with other medical devices.It is probable that the kinks observed were generated when the device was withdrawn from the procedure.Also, jammed marks were observed on device surface indicating that the truetome may have gotten stuck in contact with other medical devices used in the procedure.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.Block h11 (correction): section e has been corrected using the technician's information as it was the technician who reported the event.

• Brand Name: TRUETOME 49
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12332334
• MDR Text Key: 266922090
• Report Number: 3005099803-2021-04071
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729827627
• UDI-Public: 08714729827627
• Combination Product (y/n): N
• PMA/PMN Number: K122203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2023
• Device Model Number: M00584160
• Device Catalogue Number: 8416
• Device Lot Number: 0026606696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Date Manufacturer Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 70