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

Model Number M00535920

Device Problems Break (1069); Material Integrity Problem (2978)

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

Event Date 04/29/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon 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 intended to be used in the common bile duct (cbd) in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During preparation outside the patient, upon unpacking the device, it was noticed that the handle was detached and the cutting wire was broken which could not be used in the procedure.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.

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 at the handle section was broken.The plastic handle did not have any visual problem.Additionally, the working length was twisted at the distal section.The device was observed under magnification and the cut of the cutting wire was not smooth.Additionally, there was evidence of bending forces was observed at the broken area.X-ray inspection was performed, and it was found that the cannula at the handle section was kinked.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 at the handle section.Additionally, the cannula at the handle section was kinked.Evidence of bending forces was observed at the broken area.Based on the condition of the device, the problem found could have been caused due to the kink of the cannula in the handle causing friction with the cutting wire during the handle actuation.It was also found that the working length was twisted which could have been due to handling and manipulation of the device during unpacking/prepping/testing.Based on all gathered information, the most probable root cause of this complaint is cause traced to component failure.An investigation to address this event has been completed.The investigation concluded that there are multiple factors that are controlled by process inspections that would have to occur to generate this failure.The investigation could not confirm any commonality regarding recurrence of product builders or step omission; therefore, the cause of the component failure is undetermined.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that an ultratome xl was intended to be used in the common bile duct (cbd) in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2021.During preparation outside the patient, upon unpacking the device, it was noticed that the handle was detached and the cutting wire was broken which could not be used in the procedure.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.

• 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: 11877013
• MDR Text Key: 254600359
• Report Number: 3005099803-2021-02339
• 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: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2022
• Device Model Number: M00535920
• Device Catalogue Number: 3592
• Device Lot Number: 0025501040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Date Manufacturer Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 76