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

Model Number	20188
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2018 as no event date was reported.
Event or Problem Description
It was reported that stent dislodgment occurred.During preparation of a 7.0mmx19mmx90cm express sd renal/biliary stent, upon insertion into the sheath, the stent came off the stent delivery balloon.The device never entered the patient's body.No patient complications were reported.
Event or Problem Description
It was reported that stent dislodgment occurred.During preparation of a 7.0mmx19mmx90cm express sd renal/biliary stent, upon insertion into the sheath, the stent came off the stent delivery balloon.The device never entered the patient's body.No patient complications were reported.The returned product consisted of the complaint device, mandrel and balloon protector.Visual and microscopic analysis on the outer shaft, inner shaft, balloon and tip noted that stent is flattened and damaged.The balloon was still tightly folded and the stent impression marks when it was cramped on the balloon is still visible.There is blood present in the guidewire lumen, on the stent and on the balloon folds.Inspection of the remainder of the device presented no other damage or irregularities.
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2018 as no event date was 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: 7897559
• Report Number: 2134265-2018-61180
• Device Sequence Number: 11111529
• Product Code: NIN
• UDI-Device Identifier: 08714729390527
• UDI-Public: 08714729390527
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2018

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: 05/31/2018
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0018019499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1