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

Catalog Number 0684-00-0575

Device Problems Inability to Auto-Fill (1044); Leak/Splash (1354); Optical Problem (3001)

Patient Problem Ischemia (1942)

Event Date 08/16/2023

Event Type  Injury  

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the cs300 intra-aortic balloon pump (iabp) generated a fiber optic sensor failure alarm as well as an autofill failure alarm.The physician removed the iab because ischemic bowel was identified in the patient about the same time of the alarm.They did not attempt to resume therapy and stated the iab may have had blood in the helium tubing prior to removal.The physician inflated the iab with air after removal and did not identify a leak.The physician did not believe any harm to the patient was due to the iab issue.

Manufacturer Narrative

Additional initial reporter: (b)(6).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.Complaint record id # (b)(4).

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath.The extender tubing was also returned.No blood was observed inside the iab catheter.A portion of the extracorporeal tubing was cut from the iab and not returned.A kink was found on the catheter tubing approximately 64.5cm from the iab tip.Additionally a second kink was found on the inner lumen approximately 29.7cm from iab tip.The optical fiber was found to be broken at the kinked location of 29.7cm.An underwater leak test of the balloon, catheter, y-fitting, portion of extracorporeal and extender tubing was performed and no leaks were detected.A laboratory pump test was unable to be performed due to the returned condition of the iab catheter.The optical fiber was found to be broken, confirming the reported sensor problem.We are unable to determine when this may have occurred.The evaluation was not confirmed for a leak and autofill failure.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint #(b)(4).

Event Description

N/a.

Manufacturer Narrative

Additional initial reporter information: (b)(6).Assistant nurse manager: (b)(6).The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Complaint record id # (b)(4).

Event Description

It was reported that after approximately two days of intra-aortic balloon (iab) therapy, the cs300 intra-aortic balloon pump (iabp) generated a fiber optic sensor failure alarm as well as an autofill failure alarm.The physician removed the iab because ischemic bowel was identified in the patient about the same time of the alarm.They did not attempt to resume therapy and stated the iab may have had blood in the helium tubing prior to removal.The physician inflated the iab with air after removal and did not identify a leak.The iab was in use for approximately two days.The physician did not believe any harm to the patient was due to the iab issue.

• Brand Name: SENSATION PLUS 8FR. 50CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 17686848
• MDR Text Key: 322696354
• Report Number: 2248146-2023-00547
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: 10607567108605
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000299406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CS300
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 131 KG