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

Model Number 20188

Device Problems Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2018

Event Type  malfunction  

Event Description

It was reported that stent dislodgement occurred.The target lesion was located in the heavily calcified left renal artery.A 6.0mmx18mmx150cm express sd renal/biliary stent was advanced to treat the lesion; however, difficulty advancing was encountered.The physician exerted much pressure causing the delivery system shaft to bend at the level of the stent.The stent advanced partially across the ostium of the renal artery.Upon removal of the un-deployed stent delivery system (sds), it was noted that the stent separated from the balloon shaft but remained on the wire.The sds was advanced up to level of stent and partial recapture accomplished.The stent was pulled back into the sheath and the entire sds, sheath, and the stent were removed from the patient's body.The procedure was ended and the patient will return for the same procedure, but using a different approach.No patient complications were reported and the patient was fine.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8092419
• MDR Text Key: 128030661
• Report Number: 2134265-2018-63047
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08714729484844
• UDI-Public: 08714729484844
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0022454778
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2018
• Initial Date FDA Received: 11/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR