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

Model Number	20188
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the calcified renal artery.A 4.0mmx19mmx90cm express sd renal/biliary stent was advanced for treatment.However, during procedure, the stent was detached from the balloon.The device was removed by pulling it out on the catheter, and the procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: 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 that the stent has been pulled over the tip of the device.The middle of the stent is flattened and there is a kink to the shaft 78.9cm from the hub.Microscopic examination revealed no additional damages.The balloon is still tightly folded and there are still crimp marks on the balloon.Inspection of the remainder of the device presented no damage or irregularities.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the calcified renal artery.A 4.0mmx19mmx90cm express sd renal/biliary stent was advanced for treatment.However, during procedure, the stent was detached from the balloon.The device was removed by pulling it out on the catheter, and the procedure was completed with a different device.There were no patient complications 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
• MDR Report Key: 12017435
• Report Number: 2134265-2021-07638
• Device Sequence Number: 4636932
• Product Code: NIN
• UDI-Device Identifier: 08714729390466
• UDI-Public: 08714729390466
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

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: 02/11/2023
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0025196490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1