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

Model Number 20188

Device Problems Break (1069); Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2019

Event Type  malfunction  

Event 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 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.

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
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8632978
• MDR Text Key: 145832137
• Report Number: 2134265-2019-05587
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08714729484844
• UDI-Public: 08714729484844
• Combination Product (y/n): N
• PMA/PMN Number: K152607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 05/06/2019
• Initial Date FDA Received: 05/22/2019
• Supplement Dates Manufacturer Received: 07/14/2019
• Supplement Dates FDA Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1