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 Consequences Or Impact To Patient (2199)
Date of Event	09/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgment occurred.The 100% stenosed target lesion was located in the mildly tortuous and severely calcified iliac vessel.A 6.0mm x 18mm x 150cm express sd renal/biliary stent was advanced to treat the lesion.However, upon inserting the device, the stent came off the balloon and became stuck in the patient's femoral artery.The physician attempted to pull the stent out with a different balloon but was unsuccessful.The or team was then called to perform a cutdown to remove the stent.No further patient complications were reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of 55cm of the distal shaft, hypotube, stent, balloon and tip of an express sd catheter.The proximal end of the hypotube and hub were not returned.The balloon is loosely folded.The hypotube, outer shaft, inner shaft, balloon, stent and tip were visually and microscopically examined.The hypotube is separated 55cm from the distal tip.There are numerous hypotube and shaft kinks.The stent is pushed proximally on the shaft and is severely damaged.The tip is damaged.Inspection of the remainder of the device and stent presented no other damage or irregularities.
Event or Problem Description
It was reported that stent dislodgment occurred.The 100% stenosed target lesion was located in the mildly tortuous and severely calcified iliac vessel.A 6.0mm x 18mm x 150cm express sd renal/biliary stent was advanced to treat the lesion.However, upon inserting the device, the stent came off the balloon and became stuck in the patient's femoral artery.The physician attempted to pull the stent out with a different balloon but was unsuccessful.The or team was then called to perform a cutdown to remove the stent.No further patient complications were reported and the patient was stable.

• 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
• MDR Report Key: 9198747
• Report Number: 2134265-2019-12457
• Device Sequence Number: 3031198
• Product Code: NIN
• UDI-Device Identifier: 08714729484844
• UDI-Public: 08714729484844
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K152607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2019

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: 07/09/2021
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0022354965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR