MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 7.5FR 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0567

Device Problem Leak/Splash (1354)

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

Event Date 02/19/2024

Event Type  malfunction  

Event Description

It was reported that during intra-aortic balloon (iab) therapy, there were kink alarms, pressure alarms, and loss of helium alarms beginning on 14feb2024 into 15feb2024.It was noted that the iab had been inserted on (b)(6) 2024.The insertion was reported to be axillary, which is not the method described in the device instructions for use.On (b)(6) 2024 at 2:20am, fill volume decreased to 37ml.On (b)(6) 2024 at 4:15am, fill volume decreased to 33ml.On (b)(6) 2024 at 12:20pm, fill volume increased to 36ml after repositioning at bedside.Then, on (b)(6) 2024, fill volume decreased to 32ml.The registered nurse (rn) noted blood in the helium line when responding to the kink/helium loss alarm at 2:05pm.The line was clamped and the critical care md and cardiology were made aware.They awaited act results then the iab was removed at approximately 4:00pm on (b)(6) 2024.The catheter was replaced on (b)(6) 2024.There was no patient harm or adverse event reported.

Manufacturer Narrative

Initial reporter: (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.Reference complaint # (b)(4).

Manufacturer Narrative

The product was returned with the membrane completely unfolded with blood on the interior and exterior of the catheter.The extender tubing was also returned.A visual examination of the product detected the inner lumen within the catheter tubing was completely separated within a kink approximately 76.2cm from iab tip.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and no other leaks were detected.The evaluation determined an inner lumen break within a catheter and inner lumen kink causing the reported problems.It is difficult to determine when or how this occurred.The insertion was reported to be axillary, which is not the method described in the device instructions for use.This may have contributed to the iab failure.The evaluation confirmed the reported problems.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 7.5FR 40CC 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: 18839040
• MDR Text Key: 337022805
• Report Number: 2248146-2024-00135
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108063
• UDI-Public: 10607567108063
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0567
• Device Lot Number: 3000319345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 70 KG