MAUDE Adverse Event Report: MAQUET GETINGE GROUP / DATASCOPE CORP. FIBER-OPTIC BALLOON CATHETER, AND INSERTION KIT

Catalog Number 0684-00-0469-01U

Device Problem Pumping Problem (3016)

Patient Problems Myocardial Infarction (1969); Cardiogenic Shock (2262)

Event Date 05/14/2018

Event Type  malfunction  

Event Description

A (b)(6) female presented per ems with st elevation myocardial infarction / cardiogenic shock and taken directly to the cardiac cath lab for diagnostic and interventional catheterization.During the insertion of the catheter when the cath lab staff connected the fiber optic (orange) cable to machine / pump, it did not work.Staff then connected to the arterial line and used the balloon pump without the fiber optic.Once the catheter was removed in the icu, the catheter was returned to the cath lab manager.Fiber-optic balloon catheter and insertion kit, sensation 7fr, with 6" introducer, 34 cc iab catheter.Upn #(b)(4).

• Brand Name: FIBER-OPTIC BALLOON CATHETER, AND INSERTION KIT
• Type of Device: FIBER-OPTIC BALLOON CATHETER
• Manufacturer (Section D): MAQUET GETINGE GROUP / DATASCOPE CORP.; fairfield NJ 07004
• MDR Report Key: 7697758
• MDR Text Key: 114538851
• Report Number: MW5078461
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2020
• Device Catalogue Number: 0684-00-0469-01U
• Device Lot Number: 3000053817
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 90 YR
• Patient Weight: 63