MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS LD ILIAC / BILIARY; STENT, ILIAC

Model Number	20226
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment on guidewire occurred.The target lesion was located in iliac artery.A 10.0x30x75cm express ld iliac / biliary stent was advanced for treatment.However, during the procedure, the stent delivery system was stuck on the wire.The delivery system and the wire were removed as a whole all together.The procedure was completed with another express ld stent.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that catheter entrapment on guidewire occurred.The target lesion was located in iliac artery.A 10.0x30x75cm express ld iliac / biliary stent was advanced for treatment.However, during the procedure, the stent delivery system was stuck on the wire.The delivery system and the wire were removed as a whole all together.The procedure was completed with another express ld stent.There were no patient complications nor injuries reported.It was further reported via attached facility medwatch report 3600510000-2023-8002, the patient was being treated with abdominal angiogram with runoff and possible percutaneous transluminal angioplasty (pta).The stent was stuck on 035 amplatz platinum wire and failed to deploy.The patient condition was stable post-procedure.
Additional Manufacturer Narrative
(b)(6).

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• 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: 16404967
• Report Number: 2124215-2023-05918
• Device Sequence Number: 17550793
• Product Code: NIO
• UDI-Device Identifier: 08714729392071
• UDI-Public: 08714729392071
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2023

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: 08/08/2025
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0029919092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2022
• 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 Age: 81 YR
• Patient Sex: Male
• Patient Weight: 58 KG
• Patient Race: White