MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 7130

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

No event date provided, used the first date of the month of the aware date 01oct2018.

Event Description

Reportable based on device analysis completed on 04oct2018.This 3.00mm x 8mm emerge balloon catheter was received with no reported issues.However, returned device analysis revealed separated hypotube.Device evaluated by manufacturer: the returned product consisted of an emerge balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the hypotube.The hypotube is separated 79.6cm from the hub.Microscopic examination revealed that the tip is damaged and the balloon is loose.There is blood present in the hub, inflation lumen, and balloon.The broken shaft was connected to a tuohy adapter and stopcock then inflated using a balloon inflation device to check for possible damages to the balloon.The balloon was inflated to rbp of 14atm and could hold pressure for 5 minutes before it was deflated.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8005690
• MDR Text Key: 125101363
• Report Number: 2134265-2018-62303
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729806547
• UDI-Public: 08714729806547
• Combination Product (y/n): N
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 10/25/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2020
• Device Model Number: 7130
• Device Catalogue Number: 7130
• Device Lot Number: 0021905159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Initial Date Manufacturer Received: 10/04/2018
• Initial Date FDA Received: 10/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2018
• 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