MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC

Model Number 26280

Device Problem Premature Activation (1484)

Patient Problem No Patient Involvement (2645)

Event Date 10/23/2018

Event Type  malfunction  

Event Description

It was reported that stent was inadvertently deployed.The target lesion was located in the iliac vein.A 24x70/11fr uni plus 75cm wallstent endoprosthesis was selected for use.When the stent was flushed during preparation, it was noted that the tip of the stent was exposed.The device was replaced with another stent which was placed successfully.Following stent implantation, an 18-4/5.8/75 xxl esophageal balloon catheter was advanced for post-dilatation.However, during the first inflation at 5 atmospheres, the balloon ruptured.The device was replaced with another of the same device and the procedure was completed.There were no patient complications and the patient was fine.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; ,; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8065345
• MDR Text Key: 127066164
• Report Number: 2134265-2018-62798
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 08714729204176
• UDI-Public: 08714729204176
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2020
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0022369211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1