MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS LD BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	20226
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage and removal difficulties occurred.The 80% stenosed target lesion was located in the non-tortuous and moderately calcified superficial femoral artery.A 5.0 x 40 x 135cm express ld biliary stent was advanced for treatment.However, as the device was being moved into position for deployment, resistance was felt in advancing forward.The device was removed with resistance encountered, it was then noted that the mid way section of the stent strut was protruding from the catheter and looked damage.The device was removed intact through normal procedure.The procedure was completed successfully with a new stent.No patient complications were reported.The patient was stable and fully recovered.
Additional Manufacturer Narrative
Device evaluated by mfr.: express biliary ld pmtd 5.0x40x135cm, batch# 30718008 was received for analysis.A visual examination of the returned device confirmed that the balloon had not been subjected to positive pressure.No issues were noted with the balloon material.The device was received with stent fully mounted in the correct position on the delivery system.A visual examination identified that a strut located in the 10th distal row was lifted distally.This type of damage is consistent with excessive force being applied to the device, potentially when inserting it into the sheath/guide.A visual examination identified no issues with the tip of the device.A visual and tactile examination identified no kinks or damage to the shaft of the device.This concludes the product analysis.
Event or Problem Description
It was reported that stent damage and removal difficulties occurred.The 80% stenosed target lesion was located in the non-tortuous and moderately calcified superficial femoral artery.A 5.0 x 40 x 135cm express ld biliary stent was advanced for treatment.However, as the device was being moved into position for deployment, resistance was felt in advancing forward.The device was removed with resistance encountered, it was then noted that the mid way section of the stent strut was protruding from the catheter and looked damage.The device was removed intact through normal procedure.The procedure was completed successfully with a new stent.No patient complications were reported.The patient was stable and fully recovered.

• Brand Name: EXPRESS LD 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; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16665849
• Report Number: 2124215-2023-13446
• Device Sequence Number: 6606782
• Product Code: FGE
• UDI-Device Identifier: 08714729484974
• UDI-Public: 08714729484974
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2023

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: 12/14/2025
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0030718008
• 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: 03/13/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2022
• 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