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 07/03/2019

Event Type  malfunction  

Manufacturer Narrative

Patients exact age is unknown; however, it was reported that the patient was under the age of 18.(b)(6).(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 biliary during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the cutting wire orientation was incorrect.The procedure was completed with another ultratome xl.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 stable.

Manufacturer Narrative

Patients exact age is unknown; however, it was reported that the patient was under the age of 18.(b)(6).Block h10: visual examination of the returned device revealed that the working length was twisted in the distal section.Functionally, the device was inserted into the duodenoscope and the orientation was out of specifications due to the twisted distal section.The complaint was consistent with the reported event of incorrect orientation which was directly affected by the twisted working length.It is most likely that the issue was caused during manipulation of the device or due to the interaction with the endoscope or with other devices; that said, the most probable cause of this complaint is adverse event related to procedure, 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 biliary during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the cutting wire orientation was incorrect.The procedure was completed with another ultratome xl.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 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: 8837073
• MDR Text Key: 152521577
• Report Number: 3005099803-2019-03833
• 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: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2020
• Device Model Number: M00535920
• Device Catalogue Number: 3592
• Device Lot Number: 0022315022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1