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

Model Number M00535920

Device Problems Break (1069); Failure to Align (2522); Material Twisted/Bent (2981)

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

Event Date 08/28/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a050701 captures the reportable event of cutting wire was unable to release the bow.

Event Description

It was reported to boston scientific corporation that an ultratome xl was being prepared for use in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During preparation, before the procedure started, it was noticed that the device was damaged.The device was twisted, and the cutting wire bowed correctly but would not release the bow.The procedure was completed with another device.The exact device used to complete the procedure was unknown.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.Note: a video of the complaint device outside the patient was provided by the customer and showed the device was twisted and it was in bowed position and the cutting wire would not unbow.

Manufacturer Narrative

Block h6: imdrf device code a050701 captures the reportable event of cutting wire was unable to release the bow.Block h10: the returned ultratome xl was analyzed, and a visual evaluation noted that the working length was kinked and twisted.The working length was kinked at the hypotube section.Additionally, the wire was broken at the handle section.Per media inspection on the provided video, it showed that the device was twisted, and the wire was unable to release the bow (unbow).No other problems with the device were noted.The reported event of device would not release the bow was confirmed.Upon analysis, it was found that the wire was broken and kinked at the handle section, consequently, causing the wire unable to release the bow.It was also found that the device was kinked at the middle of the working length and at the hypotube section.Based on the condition of the device, the problem found could have been generated due to handling and manipulation of the device during its use can lead to kink/bending of the working length at the proximal section.It is possible that the kink at the proximal section could have caused some internal tension forces between the cannula and the wire during the handle actuation or too much force during handle actuation causing tension on the wire, affecting the overall performance of the device and lead to breaking it.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.

Event Description

It was reported to boston scientific corporation that an ultratome xl was being prepared for use in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During preparation, before the procedure started, it was noticed that the device was damaged.The device was twisted, and the cutting wire bowed correctly but would not release the bow.The procedure was completed with another device.The exact device used to complete the procedure was unknown.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.Note: a video of the complaint device outside the patient was provided by the customer and showed the device was twisted and it was in bowed position and the cutting wire would not unbow.

Manufacturer Narrative

Block h6: imdrf device code a050701 captures the reportable event of cutting wire was unable to release the bow.Block h10: the returned ultratome xl was analyzed, and a visual evaluation noted that the working length was kinked and twisted.The working length was kinked at the hypotube section.Additionally, the wire was broken at the handle section.Per media inspection on the provided video, it showed that the device was twisted, and the wire was unable to release the bow (unbow).No other problems with the device were noted.The reported event of device would not release the bow was confirmed.Upon analysis, it was found that the wire was broken and kinked at the handle section, consequently, causing the wire unable to release the bow.It was also found that the device was kinked at the middle of the working length and at the hypotube section.Based on the condition of the device, the problem found could have been generated due to handling and manipulation of the device during preparation that led to kinking/bending of the working length at the proximal section.It is possible that the kink at the proximal section could have caused some internal tension forces between the cannula and the wire during the handle actuation or too much force during handle actuation causing tension on the wire, affecting the overall performance of the device and lead to breaking it.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 being prepared for use in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2023.During preparation, before the procedure started, it was noticed that the device was damaged.The device was twisted, and the cutting wire bowed correctly but would not release the bow.The procedure was completed with another device.The exact device used to complete the procedure was unknown.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.Note: a video of the complaint device outside the patient was provided by the customer and showed the device was twisted and it was in bowed position and the cutting wire would not unbow.

• 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: 17980914
• MDR Text Key: 326302108
• Report Number: 3005099803-2023-05596
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729103318
• UDI-Public: 08714729103318
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00535920
• Device Catalogue Number: 3592
• Device Lot Number: 0030009166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2022
• 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