MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS LD ILIAC / BILIARY; STENT, ILIAC

Model Number 20226

Device Problem Entrapment of Device (1212)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019; used (b)(6) 2019 as event date since the correct date was not provided.

Event Description

It was reported that catheter entrapment occurred.A 7.0x30x75cm express ld iliac/biliary stent was selected for use.However, during preparation, it was noted that the stent got caught over the wire.There were no patient complications reported.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Type of Device: STENT, ILIAC
• 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: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8776148
• MDR Text Key: 150565823
• Report Number: 2134265-2019-07914
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729579663
• UDI-Public: 08714729579663
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/10/2019

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: 10/09/2020
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0021237716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2019
• Initial Date FDA Received: 07/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2017
• 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
• Patient Age: 59 YR
• Patient Weight: 95