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

Model Number	20188
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulty occurred.A 6.0mmx18mmx150cm express sd renal/biliary stent was advanced for treatment.However, during procedure, it was noted that the stent delivery system would not come back through the 5f sheath.The balloon was completely deflated, so the wire, balloon and the guide had to be removed.The procedure was completed with imaging, from a pig tail catheter.The physician was not able to rewire and engage the stent for post images.The procedure was completed.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that removal difficulty occurred.A 6.0mmx18mmx150cm express sd renal/biliary stent was advanced for treatment.However, during procedure, it was noted that the stent delivery system would not come back through the 5f sheath.The balloon was completely deflated, so the wire, balloon and the guide had to be removed.The procedure was completed with imaging, from a pig tail catheter.The physician was not able to rewire and engage the stent for post images.The procedure was completed.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an express sd stent delivery system with no stent.There was contrast in the shaft and balloon.The balloon was loosely folded and showed signs of previous inflation.There was no damage noted to the device.

• Brand Name: EXPRESS SD RENAL/BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 11019519
• Report Number: 2134265-2020-17898
• Device Sequence Number: 17099626
• Product Code: NIN
• UDI-Device Identifier: 08714729484844
• UDI-Public: 08714729484844
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K152607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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: 01/29/2023
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0025128409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1