MAUDE Adverse Event Report: DATASCOPE FAIRFIELD; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0475

Device Problem Improper Flow or Infusion (2954)

Patient Problem Death (1802)

Event Date 06/10/2016

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the manufacturer however, at this time, it has not been evaluated.When an assessment of the affected product is complete a supplemental report with our additional findings will be provided.(b)(4).

Event Description

A 7.5 40cc balloon was inserted into the patient and it worked ok.On the second day the device worked for about forty-two hours then the nurse found a lot of blood inside the catheter.They stopped pumping and immediately removed the balloon, another balloon was inserted and therapy was completed.The doctor felt the patient death was unrelated to the balloon and primarily due to ongoing serious heart disease.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter and between the catheter and the sheath.The extension tubing was also returned.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extension tubing was performed and one leak was detected on the membrane approximately 1.5cm from the rear seal measuring 0.051cm in length.The reported problem was most likely triggered by a leak which was found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.(b)(4).

Event Description

A 7.5 40 cc balloon was inserted into the patient and it worked ok.On the second day the device worked for about forty-two hours then the nurse found a lot of blood inside the catheter.They stopped pumping and immediately removed the balloon, another balloon was inserted and therapy was completed.The doctor felt the patient death was unrelated to the balloon and primarily due to ongoing serious heart disease.

• 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: 5820799
• MDR Text Key: 50386952
• Report Number: 2248146-2016-00057
• 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,consum
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2019
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000023549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2016
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 06/24/2016
• Initial Date FDA Received: 07/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2016
• 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: 78 YR