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	09/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement and catheter entrapment which requires surgery was encountered.Vascular access was obtained via the radial artery.A 7.0mmx19mmx150cm express sd catheter was advanced for treatment after the radial artery puncture which was passed by 0.014 wire on 7fr sheath.However, while passing through the sheath and radial artery, the stent got caught in the calcified lesion and fell out of the balloon.The stent remaining in the blood vessel is removed during op after the procedure.The procedure was completed with a different device.There were no patient complications reported.Patient was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an express sd stent.Visual examination revealed multiple kinks along the shaft.Microscopic examination revealed no additional damages.The stent is missing and did not return for analysis.Inspection of the remainder of the device presented no damage or irregularities.Product analysis confirmed that the stent is no longer on the balloon.
Event or Problem Description
It was reported that stent dislodgement and catheter entrapment which requires surgery was encountered.Vascular access was obtained via the radial artery.A 7.0mmx19mmx150cm express sd catheter was advanced for treatment after the radial artery puncture which was passed by 0.014 wire on 7fr sheath.However, while passing through the sheath and radial artery, the stent got caught in the calcified lesion and fell out of the balloon.The stent remaining in the blood vessel is removed during op after the procedure.The procedure was completed with a different device.There were no patient complications reported.Patient was fine.

• 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: 17846874
• Report Number: 2124215-2023-49710
• Device Sequence Number: 7173453
• Product Code: NIN
• UDI-Device Identifier: 08714729390510
• UDI-Public: 08714729390510
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/18/2026
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0030885383
• 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: 09/06/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male