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

Model Number M00535900

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

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

Event Date 03/09/2021

Event Type  malfunction  

Manufacturer Narrative

(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 duodenal-papilla during an endoscopic retrograde cholangiopancreatography (ercp) and stone removal procedure performed on (b)(6) 2021.During the procedure, when they physician adjusted the handle to perform papillotomy, the "guide bursts." the device was removed, and the procedure was completed with another of the same 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.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Note: photos of the complaint device were provided showing the device outside the patient with the cutting wire broken.

Event Description

It was reported to boston scientific corporation that an ultratome xl was used in the duodenal-papilla during an endoscopic retrograde cholangiopancreatography (ercp) and stone removal procedure performed on (b)(6) 2021.During the procedure, when they physician adjusted the handle to perform papillotomy, the "guide bursts." the device was removed, and the procedure was completed with another of the same 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.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Note: photos of the complaint device were provided showing the device outside the patient with the cutting wire broken and kinked/bent.

Manufacturer Narrative

Block h6 (device codes): medical device problem code a0401 captures the reportable event of cutting wire broken.Block h10: the device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.Block h11 (correction): the note in b5 has been corrected stating that based on the photos, the cutting wire was also kinked/bent note: photos of the complaint device were provided showing the device outside the patient with the cutting wire broken and kinked/bent.Block h6 (device codes) has also been updated.

Manufacturer Narrative

Block h6 (device codes): medical device problem 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 cutting wire was broken, blackened, and bent.The cutting wire was observed under magnification and the cutting wire was blackened, and the cut of the cutting wire was not smooth.Per media analysis, it showed that the cutting wire was broken and bent.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 bent.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 there was contact between the device and the scope during energization or if the device exceeded the maximum of voltage rating during procedure as per precautions of the device states.Also, kinking of the cutting wire can lead to break the wire.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.

Event Description

It was reported to boston scientific corporation that an ultratome xl was used in the duodenal-papilla during an endoscopic retrograde cholangiopancreatography (ercp) and stone removal procedure performed on (b)(6)2021.During the procedure, when they physician adjusted the handle to perform papillotomy, the "guide bursts." the device was removed, and the procedure was completed with another of the same 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.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Note: photos of the complaint device were provided showing the device outside the patient with the cutting wire broken and kinked/bent.

• Brand Name: ULTRATOME XL
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11599230
• MDR Text Key: 243403890
• Report Number: 3005099803-2021-01236
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729103257
• UDI-Public: 08714729103257
• Combination Product (y/n): N
• PMA/PMN Number: K930022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2022
• Device Model Number: M00535900
• Device Catalogue Number: 3590
• Device Lot Number: 0025356886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Date Manufacturer Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 79