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 Problems Material Deformation (2976); Optical Problem (3001); Pressure Problem (3012)

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

Event Date 08/18/2023

Event Type  malfunction  

Manufacturer Narrative

Occupation: (b)(6) complete event site name: (b)(6) event site postal code: (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).

Event Description

It was reported that after approximately five days of intra-aortic balloon (iab) therapy a fiber optic sensor failure occurred.Therapy was continued by obtaining the blood pressure information from an external monitor.It is believed that the fiber optic may have broken due to the patient moving around a lot and bending their leg.It was noted that another manufacturer's sheath had been used and a kink was seen on the sheath.There was no patient harm or adverse event reported.

Manufacturer Narrative

Device evaluation: the product was returned with the membrane completely unfolded and blood on the exterior of the catheter and a non- maquet sheath was returned over the membrane.Five kinks were observed on the catheter approximately 75.7 cm, 71.8cm, 58.4cm, 40.1cm and 26.9cm from the iab tip.The extender tubing and three-way stopcock were also returned.The optical fiber was found to be broken approximately 18.0cm from the iab tip.The evaluation confirmed the reported problem.However, we are unable to determine how this failure 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.Complaint record id # (b)(4).

• 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: 17738655
• MDR Text Key: 323312397
• Report Number: 2248146-2023-00564
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 09/13/2023
• Supplement Dates Manufacturer Received: 10/02/2023
• Supplement Dates FDA Received: 10/18/2023
• 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
• Treatment: 8FR TERUMO SHEATH