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

Model Number M00535920

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that an ultratome xl was used in the common bile duct during an endoscopic sphincterotomy (est) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the physician noticed that the orientation of the cutting wire was incorrect.In addition, the anatomy was tortuous impacting the scope positioning.The procedure was completed with a second ultratome xl.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

(b)(4).Visual examination of the returned device revealed that the initial orientation was within the specifications however, the working length of the device was found kinked in distal section that could affect the orientation of the device; consequently, confirming the reported complaint.The complaint was consistent with the reported event of cutting wire orientation incorrect.Working length kinked is an issue caused during manipulation of the device or due to the interaction with the endoscope during advancing through the endoscope, this condition and anatomical factors could caused the reported incorrect orientation.Therefore, a conclusion code of adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release to distribution.

Event Description

It was reported to boston scientific corporation that an ultratome xl was used in the common bile duct during an endoscopic sphincterotomy (est) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the physician noticed that the orientation of the cutting wire was incorrect.In addition, the anatomy was tortuous impacting the scope positioning.The procedure was completed with a second ultratome xl.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: 9196697
• MDR Text Key: 177556488
• Report Number: 3005099803-2019-05070
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

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 Expiration Date: 03/19/2021
• Device Model Number: M00535920
• Device Catalogue Number: 3592
• Device Lot Number: 0023513979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 11/15/2019
• Supplement Dates FDA Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR