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 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

The exact date of the event is unknown.The provided event date (b)(6) 2019 was chosen as a best estimate based on the date that the manufacturer became aware of the event.The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.However, it was reported that the device was not used past expiry date.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

Note: this report pertains to the first of two devices used during the same procedure.It was reported to boston scientific corporation that an ultratome xl was used in duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure.According to the complainant, during the procedure, after the cannulation and the guidewire was in the desired position, the physician attempted to perform sphincterotomy.When current was applied to the device, the cutting wire broke into half.The physician exchanged the device with a second ultratome xl; however, the cutting wire also broke into half.Reportedly, all connections were good and the generator was working fine prior to the activation.In addition, no part of the devices was detached inside the patient.The procedure was completed with a third ultratome xl, using the same generator and active cord.There were no patient complications reported as a result of this event.The patient's condition at the end of the procedure was reported to be fine.

• 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 DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8826131
• MDR Text Key: 153077610
• Report Number: 3005099803-2019-03727
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729103318
• UDI-Public: 08714729103318
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K930022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2019

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 Model Number: M00535920
• Device Catalogue Number: 3592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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