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 Restricted Flow rate (1248); Inappropriate Waveform (2536); Optical Problem (3001); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter full name: (b)(6).Additional initial reporter: (b)(6).U 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).

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.The customer was able to switch over to the inner lumen of the iab successfully.There was no patient harm or adverse event reported.

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 returned sheath was over the catheter and partially covering the rear portion of the balloon.The pressure and extender tubing were also returned.A kink was found on the catheter tubing approximately 71.6cm from the iab tip.A second kink was found on the catheter tubing and inner lumen near the y-fitting approximately 76.5cm from the iab tip.Additionally the optical fiber was found to be broken within the membrane approximately 6.1cm from iab tip.The optical fiber was found to be broken, confirming the reported problem.We are unable to determine when this may have occurred.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

Updated field(s): describe event or problem; other relevant history; medical device ¿ problem code.Additional reporter: (b)(4), clinical resource coordinator, cvicu/ccu/ (b)(6) / +(b)(6).Complaint record id #(b)(4).

Event Description

It was reported that after approximately 12 hours of intra-aortic balloon (iab) therapy, the cs300 intra-aortic balloon pump (iabp) generated a fiber optic sensor failure alarm.It was noted that the patient had come out of the operating room around 2pm on (b)(6) 2023 and the issue occurred at 2am the next morning.Six hours post-op, the patient became significantly restless and anxious.The nurse had difficulty keeping iab insertion leg immobilized.Several hours later, the console generated the fiber optic sensor failure alarm.They switched to the inner lumen to transduce but it was believed that the line was clotted.The waveform was off as well as all the hemodynamic augmentation.It was then discovered that the iab placement was very shallow so the iab was removed at 0530 on (b)(6) 2023.There were no issues after removal and the patient was transferred out of the icu the next day.There was no patient harm or adverse event reported.

Event Description

N/a.

Manufacturer Narrative

Correction to mfg follow up #2 to field h10: 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 returned sheath was over the catheter and partially covering the rear portion of the balloon.The pressure and extender tubing were also returned.A kink was found on the catheter tubing approximately 71.6cm from the iab tip.A second kink was found on the catheter tubing and inner lumen near the y-fitting approximately 76.5cm from the iab tip.Additionally the optical fiber was found to be broken within the membrane approximately 6.1cm from iab tip.The technician attempted to flush the inner lumen and was unable to do so.The technician then attempted to insert a 0.025¿ laboratory guide wire through the inner lumen and resistance was only felt at the kinked location.The optical fiber was found to be broken and a kinked inner lumen, confirming the reported problems.We are unable to determine when this may have occurred.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).

• 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: 18004796
• MDR Text Key: 327514741
• Report Number: 2248146-2023-00636
• 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,Followup
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000321167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CS300.
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 96 KG