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

Model Number	20188
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon slow deflation and removal difficulties were encountered.The stenosed target lesion was located in celiac artery.A 7.0mmx19mmx150cm express sd renal/biliary stent was deployed successfully for treatment.However, the stent balloon would not fully deflate making it difficult to withdraw the balloon.Every normal technique was made including pulling negative pressure with a syringe.The.018 wire, sheath, and the partially inflated balloon were removed as one.The patient did not experience any symptoms while the balloon remained inflated when removed.The procedure was completed successfully.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an express balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the inflation lumen is stretched in multiple locations.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon slow deflation and removal difficulties were encountered.The stenosed target lesion was located in celiac artery.A 7.0mmx19mmx150cm express sd renal/biliary stent was deployed successfully for treatment.However, the stent balloon would not fully deflate making it difficult to withdraw the balloon.Every normal technique was made including pulling negative pressure with a syringe.The.018 wire, sheath, and the partially inflated balloon were removed as one.The patient did not experience any symptoms while the balloon remained inflated when removed.The procedure was completed successfully.No patient complications were 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16618033
• Report Number: 2124215-2023-11085
• Device Sequence Number: 6164823
• Product Code: NIN
• UDI-Device Identifier: 08714729390510
• UDI-Public: 08714729390510
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K152607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 04/21/2023

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: 01/11/2025
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0028668769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2022
• 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