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

Model Number M00535920

Device Problems Use of Device Problem (1670); Device Dislodged or Dislocated (2923)

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

Event Date 05/01/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an ultratome xl was used during a gastroscopy procedure to cut an ingrown feeding tube located in the stomach.The exact procedure date was unknown.During the procedure, while cutting, the cutting wire along with its anchor (y shaped metal piece) fell into the patient's stomach.The detached part was successfully retrieved using a gastroscope with a cap.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: it was reported that the device was used in the stomach in a procedure to remove an ingrown feeding tube.However, according to the instructions for use (ifu), the tome devices are indicated for use in the selective cannulation of the common bile ducts (cbd) and the transendoscopic sphincterotomy of the papilla of vater and/or the sphincter of oddi.The sphincterotome can also be used to inject contrast medium.The reported anatomy location and procedure are not described in the indications for use.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a051201 captures the reportable event of cutting wire anchor dislodged.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a051201 captures the reportable event of cutting wire anchor dislodged.Block b5 and block h6 (impact code) have been updated based on the additional information received on june 15, 2023, and on june 19, 2023.

Event Description

It was reported to boston scientific corporation that an ultratome xl was used during a gastroscopy procedure to cut an ingrown feeding tube located in the stomach.The exact procedure date was unknown.During the procedure, while cutting, the cutting wire along with its anchor (y shaped metal piece) fell into the patient's stomach.The detached part was successfully retrieved using a gastroscope with a cap.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: it was reported that the device was used in the stomach in a procedure to remove an ingrown feeding tube.However, according to the instructions for use (ifu), the tome devices are indicated for use in the selective cannulation of the common bile ducts (cbd) and the transendoscopic sphincterotomy of the papilla of vater and/or the sphincter of oddi.The sphincterotome can also be used to inject contrast medium.The reported anatomy location and procedure are not described in the indications for use.Additional information received on june 15, 2023, and on june 19, 2023: the gastroscopy procedure was not completed due to the dislodgement of the cutting wire anchor.The procedure took longer than expected and the patient had to undergo surgery.The physician believed that the dislodgement of the cutting wire anchor did not contribute to the need for surgery as the patient's ingrown feeding tube had to be surgically removed, which was the original indication of the procedure.The surgery was performed at a later date, and it was reported that a new feeding tube was placed.

Event Description

It was reported to boston scientific corporation that an ultratome xl was used during a gastroscopy procedure to cut an ingrown feeding tube located in the stomach.The exact procedure date was unknown.During the procedure, while cutting, the cutting wire along with its anchor (y shaped metal piece) fell into the patient's stomach.The detached part was successfully retrieved using a gastroscope with a cap.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: it was reported that the device was used in the stomach in a procedure to remove an ingrown feeding tube.However, according to the instructions for use (ifu), the tome devices are indicated for use in the selective cannulation of the common bile ducts (cbd) and the transendoscopic sphincterotomy of the papilla of vater and/or the sphincter of oddi.The sphincterotome can also be used to inject contrast medium.The reported anatomy location and procedure are not described in the indications for use.Additional information received on june 15, 2023, and on june 19, 2023: the gastroscopy procedure was not completed due to the dislodgement of the cutting wire anchor.The procedure took longer than expected and the patient had to undergo surgery.The physician believed that the dislodgement of the cutting wire anchor did not contribute to the need for surgery as the patient's ingrown feeding tube had to be surgically removed, which was the original indication of the procedure.The surgery was performed at a later date, and it was reported that a new feeding tube was placed.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a051201 captures the reportable event of cutting wire anchor dislodged.Block h10: the returned ultratome xl was analyzed, and a visual evaluation noted that the cutting wire was broken from the proximal pierce hole, and the wire/anchor got dislodged/dislocated from the catheter which was consistent per media inspection on the provided photo.The device was observed under magnification, and it was found that the working length was torn from the distal pierced hole to the tip.No other problems with the device were noted.The reported event of wire/anchor dislodged was confirmed.Upon analysis, it was found that the cutting wire was broken from the proximal pierce hole, and the wire/anchor got dislodged/dislocated from the catheter.It is possible that broken wire 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.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.It was also found that the working length was torn from the distal pierced hole to the tip.It is most likely that once the cutting wire was broken, the attempt to remove it from the scope could lead to tearing the working length as observed, consequently, dislodging or dislocating the wire/anchor.A labeling review was performed and from the information available, this device was not used per the instructions for use (ifu)/product label as the device was used in the stomach; however, the ifu states "the sphincterotome is indicated for use in the selective cannulation of the common bile ducts (cbd) and the transendoscopic sphincterotomy of the papilla of vater and/or the sphincter of oddi." based on the available information and the analysis of the returned device, the most probable root cause of this complaint is cause traced to intentional off-label, unapproved, or contraindicated use due to the intentional use of the device in an unapproved procedure, for an unapproved patient, or for which it is contraindicated, or not listed on the label.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code: a051201 captures the reportable event of cutting wire anchor dislodged.Block h10: the returned ultratome xl was analyzed, and a visual evaluation noted that the cutting wire was broken, blackened, and the wire/anchor got dislodged dislocated from the catheter which was consistent per media inspection on the provided photo.The device was observed under magnification, and it was found that the working length was torn from the distal pierced hole to the tip.No other problems with the device were noted.The reported event of wire/anchor dislodged was confirmed.Upon analysis, it was found that the cutting wire was broken, blackened, and the wire anchor got dislodged/dislocated from the catheter.It is possible that broken wire 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.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.It was also found that the working length was torn from the distal pierced hole to the tip.It is most likely that once the cutting wire was broken, the attempt to remove it from the scope could lead to tearing the working length as observed, consequently, dislodging or dislocating the wire/anchor.A labeling review was performed and from the information available, this device was not used per the instructions for use (ifu)/product label as the device was used in the stomach; however, the ifu states "the sphincterotome is indicated for use in the selective cannulation of the common bile ducts (cbd) and the transendoscopic sphincterotomy of the papilla of vater and/or the sphincter of oddi." based on the available information and the analysis of the returned device, the most probable root cause of this complaint is cause traced to intentional off-label, unapproved, or contraindicated use due to the intentional use of the device in an unapproved procedure, for an unapproved patient, or for which it is contraindicated, or not listed on the label.

Event Description

It was reported to boston scientific corporation that an ultratome xl was used during a gastroscopy procedure to cut an ingrown feeding tube located in the stomach.The exact procedure date was unknown.During the procedure, while cutting, the cutting wire along with its anchor (y shaped metal piece) fell into the patient's stomach.The detached part was successfully retrieved using a gastroscope with a cap.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: it was reported that the device was used in the stomach in a procedure to remove an ingrown feeding tube.However, according to the instructions for use (ifu), the tome devices are indicated for use in the selective cannulation of the common bile ducts (cbd) and the transendoscopic sphincterotomy of the papilla of vater and or the sphincter of oddi.The sphincterotome can also be used to inject contrast medium.The reported anatomy location and procedure are not described in the indications for use.Additional information received on june 15, 2023, and on june 19, 2023: the gastroscopy procedure was not completed due to the dislodgement of the cutting wire anchor.The procedure took longer than expected and the patient had to undergo surgery.The physician believed that the dislodgement of the cutting wire anchor did not contribute to the need for surgery as the patient's ingrown feeding tube had to be surgically removed, which was the original indication of the procedure.The surgery was performed at a later date, and it was reported that a new feeding tube was placed.

• 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: 17064605
• MDR Text Key: 316881561
• Report Number: 3005099803-2023-02939
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729103318
• UDI-Public: 08714729103318
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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,Followup
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• 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: 0029629399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2022
• 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