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

Model Number M00535900

Device Problems Failure to Fold (1255); Defective Device (2588); Appropriate Term/Code Not Available (3191)

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

Event Date 08/31/2021

Event Type  malfunction  

Manufacturer Narrative

This event was reported by the distributor.The physician is: (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and 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 that an ultratome xl was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, "the physician found that the cutting wire was diverticuled on the tip of the ultratome xl and couldn't kink it".The procedure was not completed due to this event.There were no reported patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Event Description

It was reported to boston scientific corporation that an ultratome xl was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, "the physician found that the cutting wire was diverticuled on the tip of the ultratome xl and couldn't kink it".The procedure was not completed due to this event.There were no reported patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Section e: this event was reported by the distributor.The physician is: (b)(6).Block h6 (device codes): medical device problem code a27 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: the returned ultratome xl was analyzed, and a visual evaluation noted that the working length was twisted at the distal section.The distal pierced hole was also torn which displaced the cutting wire anchor from its original position (the wire anchor is still within the catheter).These conditions are consistent with the findings when the device was observed under magnification.Additionally, the cutting wire was blackened.A functional evaluation was performed by actuating the handle, and the device did not bow due to torn distal pierced hole (tome's extrusion).No other problems with the device were noted.The reported event was confirmed.Upon analysis, it was found that the cutting wire was blackened, the working length was twisted, and the distal pierced hole was torn.Based on the device condition, the wire blackened could have been generated while electrical current was applied to the tissue.Twisted working length is a problem that could have been due to multiple attempts to rotate the device or during introduction of the device into the scope or due to user technique to remove the mandrel from the distal section of the device.Moreover, working length torn at the pierce hole could have been caused by a resistance felt at the cutting wire due to twisted working length during the handle actuation causing the catheter to tear and displacing the cutting wire anchor from its position, which could result in problems when bowing the device.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.

• 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: 12532264
• MDR Text Key: 273316286
• Report Number: 3005099803-2021-04959
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729103257
• UDI-Public: 08714729103257
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

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: 04/20/2023
• Device Model Number: M00535900
• Device Catalogue Number: 3590
• Device Lot Number: 0027173177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 09/27/2021
• Supplement Dates Manufacturer Received: 12/24/2021
• Supplement Dates FDA Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2021
• 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
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 80 KG