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 11/28/2018

Event Type  Injury  

Event Description

It was reported that the stent dislodged.An express sd renal/biliary stent was selected for use for an angioplasty and stent procedure in the left renal artery.During the procedure, the stent became dislodged off of the balloon at the location of the left renal artery.The stent expanded with no additional problems and there were no patient complications reported.

• 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: 8161980
• MDR Text Key: 130262209
• Report Number: 2134265-2018-64081
• 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: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2020
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0021133230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2017
• 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
• Treatment: 300CM V-18 GUIDEWIRE; 5X20MM STERLING RX PRE-DILATATION BALLOON; 6FR X 11CM SHEATH; 6FR X 55CM LIMA MACH 1 GUIDE CATHETER
• Patient Age: 84 YR