MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRATOME XL; SNARE, FLEXIBLE

Model Number M00535920

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

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

Event Date 05/08/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.

Event Description

It was reported to boston scientific corporation that an ultratome xl was used in the papilla and common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.The ultratome xl was tested prior to use, and it was noticed that the cutting wire could be tightened and it was intact.The device was then positioned ready for cutting in a semi-tensed position.During the procedure, when the current was applied to the device, the cutting wire broke.Since the broke cutting wire was still hanging from the device, the entire endoscope along with the ultratome xl was removed from the patient.It was reported that no part of the device was 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.Note: a photo of the complaint device outside the patient was provided by the customer and showed the cutting wire was broken, kinked, and blackened.

Manufacturer Narrative

Block e1 (initial reporter phone): the other initial reporter phone is (b)(6).Block e1 (initial reporter email): the other initial reporter email is (b)(6).Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.Block h10: the returned ultratome xl was analyzed, and a visual evaluation noted that the distal section had the cutting wire broken, and the returned device was the detached distal section from the device, probably it was cut to remove the device from the scope to avoid damaging it.Per media analysis on the provided photos of the customer, it showed the cutting wire was broken from the proximal pierced hole, and the other photo showed the screen of the settings from the generator.The device was observed under magnification, and the cutting wire was broken, and the ends of the broken wire were blackened.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, and the ends of the broken wire were blackened.The cutting wire being blackened indicates that the device was energized.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, the physician needed to cut the distal section to remove the device from the scope, without damaging it.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 labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that an ultratome xl was used in the papilla and common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.The ultratome xl was tested prior to use, and it was noticed that the cutting wire could be tightened, and it was intact.The device was then positioned ready for cutting in a semi-tensed position.During the procedure, when the current was applied to the device, the cutting wire broke.Since the broke cutting wire was still hanging from the device, the entire endoscope along with the ultratome xl was removed from the patient.It was reported that no part of the device was 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.Note: a photo of the complaint device outside the patient was provided by the customer and showed the cutting wire was broken, kinked, and blackened.

Manufacturer Narrative

Block e1 (initial reporter phone): the other initial reporter phone is (b)(6) block e1 (initial reporter email): the other initial reporter email is (b)(6) block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.Block h2 (additional information): block h10 has been updated to reflect the information in block e1 (initial reporter phone and initial reporter email) based on the additional information received on may 16, 2023.

Event Description

It was reported to boston scientific corporation that an ultratome xl was used in the papilla and common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.The ultratome xl was tested prior to use, and it was noticed that the cutting wire could be tightened and it was intact.The device was then positioned ready for cutting in a semi-tensed position.During the procedure, when the current was applied to the device, the cutting wire broke.Since the broke cutting wire was still hanging from the device, the entire endoscope along with the ultratome xl was removed from the patient.It was reported that no part of the device was 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.Note: a photo of the complaint device outside the patient was provided by the customer and showed the cutting wire was broken, kinked, and blackened.

• Brand Name: ULTRATOME XL
• Type of Device: SNARE, FLEXIBLE
• 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: 16943194
• MDR Text Key: 315384419
• Report Number: 3005099803-2023-02668
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729103318
• UDI-Public: 08714729103318
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K930022
• 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,Followup
• Report Date: 07/10/2023

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: 12/08/2023
• Device Model Number: M00535920
• Device Catalogue Number: 3592
• Device Lot Number: 0028522412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 05/16/2023
• Supplement Dates Manufacturer Received: 05/16/2023; 06/15/2023
• Supplement Dates FDA Received: 06/08/2023; 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2021
• 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