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

Model Number 20188

Device Problems Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 12/19/2018

Event Type  Injury  

Event Description

It was reported that a dissection occurred.A 7fr 100cm guide catheter and 200cm v18 guidewire were used to access the lesion in the stenosed left renal artery.Pre-dilation was performed.A 5.0mmx15mmx150cm express sd renal/biliary and 6.0mmx18mmx150cm express sd renal/biliary were selected for use but failed to cross the stenosis after multiple attempts to be placed at the target site due to the angled renal artery.A dissection occurred at the entry of the left renal artery.Angioplasty was performed to assure normal blood flow.The patient was placed under observation and rescheduled for another renal artery stenting procedure.The patient was stable.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.The balloon was tightly folded with the stent tightly crimped over the balloon.The tip, stent, balloon, proximal weld, and shaft were microscopically and visually inspected.Inspection revealed a kink in the shaft that was located 14.5 cm from the tip of the device.Inspection of the remainder of the device found no other damage or irregularities.There was no evidence of any damage or irregularities contributing to the reported advancing difficulty and dissection, which could not be confirmed because the clinical circumstances could not be replicated.It is considered most likely that the shaft kink is attributed to procedural factors.

Event Description

It was reported that a dissection occurred.A 7fr 100cm guide catheter and 200cm v18 guidewire were used to access the lesion in the stenosed left renal artery.Pre-dilation was performed.A 5.0mmx15mmx150cm express sd renal/biliary and 6.0mmx18mmx150cm express sd renal/biliary were selected for use but failed to cross the stenosis after multiple attempts to be placed at the target site due to the angled renal artery.A dissection occurred at the entry of the left renal artery.Angioplasty was performed to assure normal blood flow.The patient was placed under observation and rescheduled for another renal artery stenting procedure.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: 8228453
• MDR Text Key: 132429063
• Report Number: 2134265-2018-64920
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08714729390398
• UDI-Public: 08714729390398
• 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: 01/30/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0022727869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Manufacturer Received: 12/19/2018
• Initial Date FDA Received: 01/08/2019
• Supplement Dates Manufacturer Received: 01/11/2019
• Supplement Dates FDA Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other