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

Model Number 20188

Device Problems Failure to Advance (2524); Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2021

Event Type  Injury  

Event Description

It was reported that stent dislodgement occurred.The target lesion was located in the renal artery.A 6.0mmx18mmx90cm express sd stent was advanced for treatment but had difficulty in going through the lesion.The physician had to retrieve the catheter; however, the stent detached and migrated to another renal artery.The stent was snared and was removed by the introducer in place.A new device was used to complete the procedure.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an express sd balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen.The balloon was tightly folded.There were crimp marks on the balloon.The stent was dislodged from the balloon and had bent struts.There was blood present on the stent.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that stent dislodgement occurred.The target lesion was located in the renal artery.A 6.0mmx18mmx90cm express sd stent was advanced for treatment but had difficulty in going through the lesion.The physician had to retrieve the catheter; however, the stent detached and migrated to another renal artery.The stent was snared and was removed by the introducer in place.A new device was used to complete the procedure.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
• MDR Report Key: 11206839
• MDR Text Key: 227921677
• Report Number: 2134265-2021-00478
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08714729484851
• UDI-Public: 08714729484851
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2022
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0023894461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention