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 Device Alarm System (1012); Difficult to Remove (1528); Contamination /Decontamination Problem (2895)

Patient Problems Death (1802); Ventricular Fibrillation (2130); Obstruction/Occlusion (2422)

Event Date 10/30/2018

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

It was reported that an intra-aortic balloon (iab) was inserted without complication, however brown spots were found in the inflatable tubing.The consoled did not alarm.However the console did eventually alarm "auto fill failure" and "check iab catheter." additional blood was noted and an attempt to remove the catheter was made, but it could not be removed.All interventional procedures in the customer's cath lab were not available, and abdominal aortography was shown in the abdomen.The aorta was obstructed and the patient expired after ventricular fibrillation.The iab was still not removed from the patient, and it was cut to leave part of the external extension tube.

• 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: 8086404
• MDR Text Key: 127844850
• Report Number: 2248146-2018-00671
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2021
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000073085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/24/2018
• 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: 64 YR
• Patient Weight: 68