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	12/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that the stent dislodged from the balloon.A 7.0mmx15mmx150cm express sd balloon expandable stent was selected for use to treat peripheral artery disease (pad).The target lesion was located in the iliac artery and was noted as mildly calcified.The stent delivery system was advanced to the target lesion.However, the stent dislodged from the balloon prematurely and deployed in an unintended location.The stent was not removed.A new express sd stent was used and implanted in the correct location.There were no patient complications.
Additional Manufacturer Narrative
E1 - initial reporter facility name: vascular and interventional experts.
Event or Problem Description
It was reported that the stent dislodged from the balloon.A 7.0mmx15mmx150cm express sd balloon expandable stent was selected for use to treat peripheral artery disease (pad).The target lesion was located in the iliac artery and was noted as mildly calcified.The stent delivery system was advanced to the target lesion.However, the stent dislodged from the balloon prematurely and deployed in an unintended location.The stent was not removed.A new express sd stent was used and implanted in the correct location.There were no patient complications.It was further reported that no additional intervention was needed and the stent was left in a spot that did not add any complications to the procedure.The patient recovered fully with out issue.

• 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: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13155797
• Report Number: 2134265-2021-16251
• Device Sequence Number: 20186595
• Product Code: NIN
• UDI-Device Identifier: 08714729390435
• UDI-Public: 08714729390435
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K152607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2022

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: 09/09/2023
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0025987051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/09/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2020
• 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: Male