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

Catalog Number 0684-00-0497

Device Problem Material Rupture (1546)

Patient Problems Death (1802); Embolism (1829); Loss of consciousness (2418)

Event Date 09/11/2017

Event Type  Death  

Manufacturer Narrative

The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.(b)(4).

Event Description

Customer reported that while in use on a patient, the intra-aortic balloon (iab) ruptured resulting in helium emboli and decreased level of consciousness.The patient expired, but the date of death is unknown.

Manufacturer Narrative

Patient date of death received on 10october2017.The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint # (b)(4).

Event Description

Customer reported that while in use on a patient, the intra-aortic balloon (iab) ruptured resulting in helium emboli and decreased level of consciousness.The patient expired, but the date of death is unknown.

• Brand Name: MEGA 8FR. 50CC 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: 6915619
• MDR Text Key: 88210950
• Report Number: 2248146-2017-00438
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K091449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/17/2020
• Device Catalogue Number: 0684-00-0497
• Device Lot Number: 3000045495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 10/10/2017
• Date Device Manufactured: 02/17/2017
• 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: 55 YR
• Patient Weight: 73