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

Catalog Number 0684-00-0575

Device Problems Device Contamination with Body Fluid (2317); Device Displays Incorrect Message (2591); Gas/Air Leak (2946); Improper Flow or Infusion (2954); Torn Material (3024)

Patient Problem Death (1802)

Event Date 07/25/2016

Event Type  Death  

Manufacturer Narrative

The device has not been returned to the manufacturer and we're unable to complete an evaluation on the affected product.When its' provided we will send a supplemental report with additional findings.We continue in our efforts to follow up with the customer for its' return.(b)(4).

Event Description

The patient had a 50cc iab catheter inserted; at approximately 0553 hours the balloon began to alarm ¿gas loss in circuit¿.At this time all connections were checked and no blood was observed.The balloon began to auto fill, restarted and quickly alarmed again, upon inspection the catheter and helium lines had blood in them.The catheter was removed to prohibit the flow of blood and a new balloon was used.When the replacement balloon was inserted it was found to be torn, a third balloon was subsequently used and therapy restarted.At about 12:35 it began to alarm, ¿gas loss in circuit¿ and blood was also found in both the helium and catheter lines.The therapist clamped both lines and the balloon was removed by the physician.At this time it was decided to not replace the third balloon as it was going to be removed that day anyway.Roughly an hour later the patient expired.

Manufacturer Narrative

Date rec'd by mfr was not entered in the initial mdr.Date: 07/25/2016.

Event Description

The patient had a 50cc iab catheter inserted; at approximately 0553 hours the balloon began to alarm ¿gas loss in circuit¿.At this time all connections were checked and no blood was observed.The balloon began to auto fill, restarted and quickly alarmed again, upon inspection the catheter and helium lines had blood in them.The catheter was removed to prohibit the flow of blood and a new balloon was used.When the replacement balloon was inserted it was found to be torn, a third balloon was subsequently used and therapy restarted.At about 12:35 it began to alarm, ¿gas loss in circuit¿ and blood was also found in both the helium and catheter lines.The therapist clamped both lines and the balloon was removed by the physician.At this time it was decided to not replace the third balloon as it was going to be removed that day anyway.Roughly an hour later the patient expired.

• Brand Name: SENSATION PLUS 8FR. 50CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 5890699
• MDR Text Key: 52608748
• Report Number: 2248146-2016-00060
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112327
• 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: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0575
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 07/25/2016
• 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: 59 YR