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

Model Number	20188
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2134265-2022-02087
• Device Sequence Number: 5332422
• Product Code: NIN
• UDI-Device Identifier: 08714729484844
• UDI-Public: 08714729484844
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K152607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/11/2024
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 04/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown