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

Model Number 20188

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2019

Event Type  Injury  

Event 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.

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 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
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9198747
• MDR Text Key: 162553363
• Report Number: 2134265-2019-12457
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08714729484844
• UDI-Public: 08714729484844
• Combination Product (y/n): N
• PMA/PMN Number: K152607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR