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

Model Number	20188
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties were encountered.Vascular access was obtained via the radial artery.The target lesion was located in the renal artery.A 5f non-bsc sheath was inserted and the lesion was engaged with a 6f non-bsc guide catheter.A 6.0mm x 18mm x 150cm express sd stent was advanced but had difficulty advancing through the guide catheter.After the stent was successfully deployed into the renal artery, the balloon that the stent was mounted on was difficult to remove from a non-bsc guide catheter; however, it was successfully removed after much force was applied.The procedure was completed with no patient complications reported.
Additional 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 and balloon.The balloon was loosely folded.The outer shaft was stretched down starting 41.8cm from the strain relief and extending 104.2cm distally.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that removal difficulties were enountered.Vascular access was obtained via the radial artery.The target lesion was located in the renal artery.A 5f non-bsc sheath was inserted and the lesion was engaged with a 6f non-bsc guide catheter.A 6.0mmx18mmx150cm express sd stent was advanced but had difficulty advancing through the guide catheter.After the stent was successfully deployed into the renal artery, the balloon that the stent was mounted on was difficult to remove from a non-bsc guide catheter; however, it was successfully removed after much force was applied.The procedure was completed with no patient complications reported.

• 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: 10362484
• Report Number: 2134265-2020-10426
• Device Sequence Number: 11364865
• Product Code: NIN
• UDI-Device Identifier: 08714729484844
• UDI-Public: 08714729484844
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K152607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2020

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: 11/14/2021
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0022944167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 09/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1