MAUDE Adverse Event Report: DATASCOPE FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0474

Device Problems Material Puncture/Hole (1504); Device Displays Incorrect Message (2591); Gas/Air Leak (2946)

Patient Problem Death (1802)

Event Date 01/23/2019

Event Type  Death  

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

Intra-aortic balloon (iab) was inserted pre-operative for post-operative mechanical support and weaning from cpb (cardiopulmonary bypass) of a poor left ventricle patient.It was reported that during iab therapy there was a gas loss alarm at time of aortotomy for aortic cannulation and appearance of ¿air¿ in aortic cannula immediately post-cannulation.It was reported there was difficulty with pressure monitoring.There was blood noted in the iab extension tubing.There was one attempted autofill, but this attempt failed and the iab was removed and replaced with a second iab.After removal, the first iab was inspected and a longitudinal slit approximately 5 cm was noted 5 cm from the tip of the iab.The second iab was inserted and used after the first balloon rupture and repositioned after the surgical procedure was completed and kept in to support the patient, but was withdrawn about 10 cm.The patient expired, but the death was not attributed to the device by the facility.This report is for the first iab used.

• Brand Name: LINEAR 7.5 FR. 34CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 8358538
• MDR Text Key: 136770818
• Report Number: 2248146-2019-00111
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2021
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000069903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 75 YR
• Patient Weight: 64