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

Model Number M00535920

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Patient's weight was reported to be approximately (b)(6).(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an ultratome xl was used in the biliary papilla during an endoscopic retrograde pancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, as they were trying to bow the device to make a cut on the biliary papilla, the cutting wire broke.Reportedly, no part of the device was detached inside the patient.The endoscope was removed from the patient with the ultratome xl inside the working channel to avoid damage to the endoscope.Once removed from the patient, the ultratome xl tip was cut, and the device was removed from the endoscope.The procedure was completed with a different papillotome.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block a4: patient's weight was reported to be approximately 70 kg.Block h6 (device codes): the problem code 1069 captures the reportable event of cutting wire broken.Block h10: the ultratome xl was not returned; however, a photo of the complaint device was provided by the complainant.Per media analysis, the picture shows that the exposed cutting wire was broken.Also, an additional failure of cutting wire bent was observed.The reported event of cutting wire break was confirmed.Based on complaint information, the reported problem was observed during the procedure when they gave tension to make the cut.Based on the condition of the device, the break in the cutting wire could have been caused by the manipulation of the device during procedure, if the device was not completely in contact with the tissue when current was applied.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 directions for use (dfu) / product label.Block h11 (correction): the procedure name in block b5 has been corrected from endoscopic retrograde pancreatography (ercp) to endoscopic retrograde cholangiopancreatography (ercp).

Event Description

It was reported to boston scientific corporation that an /was used in the biliary papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, as they were trying to bow the device to make a cut on the biliary papilla, the cutting wire broke.Reportedly, no part of the device was detached inside the patient.The endoscope was removed from the patient with the ultratome xl inside the working channel to avoid damage to the endoscope.Once removed from the patient, the ultratome xl tip was cut, and the device was removed from the endoscope.The procedure was completed with a different papillotome.There were no patient complications reported as a result of this event.

• 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: 10936772
• MDR Text Key: 219338576
• Report Number: 3005099803-2020-05626
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729103318
• UDI-Public: 08714729103318
• 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
• Report Date: 12/29/2020

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: 09/09/2021
• Device Model Number: M00535920
• Device Catalogue Number: 3592
• Device Lot Number: 0024408694
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/02/2020
• Supplement Dates Manufacturer Received: 12/07/2020
• Supplement Dates FDA Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1