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	01/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target location was located in the mildly calcified and mildly tortuous renal artery.Two stents were used in the left renal artery and one in the right renal artery.A 7.0mmx15mmx150cm express sd renal/biliary stent was advanced for treatment.However, during insertion, the distal part of the shaft broke in the sheath.The device was pulled out intact, and the procedure was completed with a new express sd renal/biliary stent.No patient complications were reported.
Additional Manufacturer Narrative
Returned product consisted of an express sd balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed kinks 28cm and 29cm from the tip.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no damage or irregularities.Product analysis could not confirm any separation but did find kinks on the device.
Event or Problem Description
It was reported that shaft break occurred.The target location was located in the mildly calcified and mildly tortuous renal artery.Two stents were used in the left renal artery and one in the right renal artery.A 7.0mmx15mmx150cm express sd renal/biliary stent was advanced for treatment.However, during insertion, the distal part of the shaft broke in the sheath.The device was pulled out intact, and the procedure was completed with a new express sd renal/biliary stent.No patient complications were reported.

• Brand Name: EXPRESS SD RENAL/BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18649145
• Report Number: 2124215-2024-06312
• Device Sequence Number: 7187168
• Product Code: NIN
• UDI-Device Identifier: 08714729390435
• UDI-Public: 08714729390435
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2024

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: 04/05/2025
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0029177873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2022
• 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