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

Model Number M00535900

Device Problems Failure to Fold (1255); Device Dislodged or Dislocated (2923)

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

Event Date 06/19/2021

Event Type  malfunction  

Manufacturer Narrative

The complainant reported two suspect device lot numbers 26417553 or 27181793; however, the correct suspect device lot number has not yet been confirmed; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and 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 an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, when they pulled the handle to bow the tip, there was a resistance felt and the pull wire that threads up from the handle going to the tip appeared to be broken.Cautery had already been performed before the problem happened.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

• 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 CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12356042
• MDR Text Key: 267824903
• Report Number: 3005099803-2021-04249
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729103257
• UDI-Public: 08714729103257
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00535900
• Device Catalogue Number: 3590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2021
• 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
• Patient Age: 71 YR