MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD MEGA 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0497

Device Problems Leak/Splash (1354); Difficult to Remove (1528)

Patient Problem Thrombus (2101)

Event Date 08/16/2019

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.(b)(4).

Event Description

It was reported that after intra-aortic balloon (iab) therapy, the customer was having difficulty removing the balloon.During therapy, blood was seen in the helium tubing and were unable to remove balloon in the intensive care unit (icu).A vascular surgeon was called and the patient sent to the operating room (or).The surgeon had cut the balloon at the shaft, just before the balloon began and some of the balloon was stuck in the iliac artery.The surgeon made a cut down incision, but was still unable to remove the balloon.Getinge representative spoke to the surgeon via phone in the operating room, suggested that there is possibility of a large clot formation in the balloon depending on how long it had been leaking.A second iab had already been placed, as the patient was unstable and had been on extracorporeal membrane oxygenation (ecmo) for a week and just taken off.Upon follow-up call to the customer, the patient spent 10 hours in the operating room and the balloon was removed.A large clot was reportedly found in the leaking balloon.

• Brand Name: MEGA 8FR. 50CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 8966444
• MDR Text Key: 159835300
• Report Number: 2248146-2019-00726
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2021
• Device Catalogue Number: 0684-00-0497
• Device Lot Number: 3000067516
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/16/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/08/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 125