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

Model Number M00535900

Device Problem Break (1069)

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

Event Date 08/27/2021

Event Type  malfunction  

Manufacturer Narrative

This event was reported by the distributor.The physician is: (b)(6).(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 used in the calculus of bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, the cutting wire of the ultratome xl broke.It was reported that the physician was able to cut the papilla twice before the cutting wire broke.Additionally, no part of the cutting wire detached and fell into the patient.The procedure was completed using 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.

Event Description

It was reported to boston scientific corporation that an ultratome xl was used in the calculus of bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, the cutting wire of the ultratome xl broke.It was reported that the physician was able to cut the papilla twice before the cutting wire broke.Additionally, no part of the cutting wire detached and fell into the patient.The procedure was completed using 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

Section e: this event was reported by the distributor.The physician is: (b)(6).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, kinked and blackened, which are consistent with the findings when the device was observed under magnification.A functional evaluation was not performed due to the condition of the device.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, and blackened.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 when energization was applied to the device constantly, generating fatigue.It is also possible that this damage has occurred when the device was activated in an incorrect position, being in contact with other medical devices.Additionally, it was found that the cutting wire was kinked, which could have been caused by the interaction with other devices or due to the manipulation of 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
• MDR Report Key: 12506268
• MDR Text Key: 272479362
• Report Number: 3005099803-2021-04889
• 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
• Report Date: 10/18/2021

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: 09/15/2022
• Device Model Number: M00535900
• Device Catalogue Number: 3590
• Device Lot Number: 0026019741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Initial Date Manufacturer Received: 08/30/2021
• Initial Date FDA Received: 09/21/2021
• Supplement Dates Manufacturer Received: 09/27/2021
• Supplement Dates FDA Received: 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 52