MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS SD RENAL/BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number 20188

Device Problem Break (1069)

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

Event Date 02/14/2022

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.A 6.0mmx18mmx150cm express sd renal/biliary stent was advanced for treatment.However, during the procedure, the shaft of the stent got buckled and snapped.The procedure was completed with a different device.There were no patient complications nor injuries reported.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an express sd stent catheter.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Visual examination revealed kinks 12.3cm, 12.4 cm and 12.9 from the distal end.Microscopic examination revealed no other damage than the kinks.Product analysis did not confirm the complaint of a break.

Event Description

It was reported that shaft break occurred.A 6.0mmx18mmx150cm express sd renal/biliary stent was advanced for treatment.However, during the procedure, the shaft of the stent got buckled and snapped.The procedure was completed with a different device.There were no patient complications nor injuries reported.

• Brand Name: EXPRESS SD RENAL/BILIARY
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13702723
• MDR Text Key: 287009605
• Report Number: 2134265-2022-02087
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08714729484844
• UDI-Public: 08714729484844
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K152607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0027295196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2021
• 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