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

Model Number	20188
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occured.The target lesion was located in the left renal artery.A 6.0mmx18mmx150cm express sd renal/biliary drug-eluting stent was advanced for treatment.However, during procedure, it was noted that they tried to advanced the stent but it would not deploy.The device broke inside the patient's body but they successfully removed it.The procedure ws completed with a different device.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that shaft break occured.The target lesion was located in the left renal artery.A 6.0mmx18mmx150cm express sd renal/biliary drug-eluting stent was advanced for treatment.However, during procedure, it was noted that they tried to advanced the stent but it would not deploy.The device broke inside the patient's body but they successfully removed it.The procedure ws completed with a different device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an express sd stent inside of the related mach 1 guide catheter with two other non bsc devices.The stent was removed from the guide catheter.The stent was microscopically examined.The express sd stent was severely damaged and broken.

• 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: 8632978
• Report Number: 2134265-2019-05587
• Device Sequence Number: 14042027
• Product Code: NIN
• UDI-Device Identifier: 08714729484844
• UDI-Public: 08714729484844
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2019

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: 09/09/2021
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0022631407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 07/14/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 07/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1