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

Catalog Number 0684-00-0605

Device Problem Leak/Splash (1354)

Patient Problem Abdominal Pain (1685)

Event Date 02/28/2022

Event Type  Injury  

Event Description

It was reported that after approximately one day of intra-aortic balloon (iab) therapy the console generated a gas loss in iab circuit alarm and a check iab catheter alarm.The patient was stable, but complained of abdominal pain so the iab was removed.Upon removal, blood was found inside the iab.The customer suspects a helium embolism.The patient was later discharged.

Manufacturer Narrative

Event site postal code: (b)(6).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Complaint record id # (b)(4).

Manufacturer Narrative

The product was returned with the membrane completely unfolded with blood on the exterior of the catheter and between the catheter and the returned non-maquet sheath.The pressure tubing was also returned.The extracorporeal tubing was returned cut at 34.3cm from the rear of the y-fitting.A catheter tubing/inner lumen/sheath kink was observed at approximately 50cm from the iab tip.At this same location, the optical fiber was found to be broken.An additional catheter tubing kink was also observed at approximately 76.2cm from the iab tip.Lastly, an inner lumen break from a severe kink was observed at approximately 24.4cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and a leak was observed at the inner lumen break site.A 0.025" guidewire was inserted into the inner lumen where a blood occlusion was felt.Unable to clear occlusion.The reported problem appears to have been caused by a kink on the inner lumen which developed into a break and causing a leak.However, we are unable to conclusively determine when this kink may have occurred.The evaluation confirmed the problem.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.(b)(4).

Event Description

N/a.

• Brand Name: TRANS-RAY PLUS 7.5 FR. 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: 13891908
• MDR Text Key: 287838736
• Report Number: 2248146-2022-00240
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2023
• Device Catalogue Number: 0684-00-0605
• Device Lot Number: 3000137769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other