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

Model Number	20188
Medical Device Problem Codes	Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	12/19/2018
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.There was blood in the wire and inflation lumens (shafts).The tip, stent, balloon, proximal weld and shaft were microscopically and visually inspected.Inspection revealed a complete separation in the outer shaft and hypotube that was located 17.3 cm from the strain relief, stent damage (stent strut lifted) located 12 mm from the tip of the device and witness marks where the stent shifted distally 2 mm on the balloon.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 crossing difficulty, 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 or Problem 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
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8228461
• Report Number: 2134265-2018-64921
• Device Sequence Number: 1997221
• Product Code: NIN
• UDI-Device Identifier: 08714729484844
• UDI-Public: 08714729484844
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K152607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0020173043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other