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

Model Number 20188

Device Problems Difficult to Remove (1528); Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2022

Event Type  Injury  

Event Description

It was reported that removal difficulties were encountered and the procedure was cancelled.The target lesion was located in the severely tortuous and mildly calcified celiac artery.A 6.0mmx18mmx150cm express sd renal/biliary stent was advanced for treatment.However, the stent failed to cross the lesion and it became stuck.The device was difficult to remove and snaring was performed.The procedure was abandoned and no patient complications were reported.

Event Description

It was reported that removal difficulties were encountered and the procedure was cancelled.The target lesion was located in the severely tortuous and mildly calcified celiac artery.A 6.0mmx18mmx150cm express sd renal/biliary stent was advanced for treatment.However, the stent failed to cross the lesion and it became stuck.The device was difficult to remove and snaring was performed.The procedure was abandoned and no patient complications were reported.It was further reported that the stent delivery system got stuck in the heavily calcified lesion.

• Brand Name: EXPRESS SD RENAL/BILIARY
• Type of Device: 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14958459
• MDR Text Key: 295509213
• Report Number: 2134265-2022-07171
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08714729484844
• UDI-Public: 08714729484844
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0029107840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention