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

Model Number 0684-00-0576-01

Device Problem Inflation Problem (1310)

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

Event Date 09/11/2021

Event Type  malfunction  

Manufacturer Narrative

Occupation: rn, bsn, ccrn, senior staff nurse.The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.(b)(4).

Event Description

It was reported that after inserting the intra-aortic balloon (iab), the customer noted that the iab would not inflate.The iab was removed and replaced with a new one without further issue.There was no patient harm or adverse event reported.

Manufacturer Narrative

The product was returned with the membrane completely unfolded with traces of blood on the exterior of the catheter.The pressure tubing was also returned.A catheter tubing/inner lumen kink was observed at approximately 66cm from the iab tip.Additionally, an optical fiber break was also observed at the catheter tubing/inner lumen kink site.An underwater leak test of the balloon, catheter tubing, y-fitting, extracorporeal tubing and pressure tubing was performed and no leaks were detected.The technician attempted to insert a 0.025¿ laboratory guidewire through the inner lumen and found to have traces of dry blood.Additionally, a guidewire insertion obstruction was felt at the inner lumen kink site.The iab was placed on the cs300 pump and did not inflate.The condition of the iab as received indicated a significant kink which restricted gas passage, resulting in poor inflation on the pump.However, we are unable to determine when this kink may have occurred.The evaluation confirmed the reported problem.A non-conforming material report review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Analysis of production ((b)(4)) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis ((b)(4)) - the review of the historical data was performed.Trend analysis ((b)(4)) - the overall complaint trend data for the period oct-19 through sep-21 was reviewed.Communication/interviews: ((b)(4)) communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).

Event Description

N/a.

• 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: 12568455
• MDR Text Key: 274491009
• Report Number: 2248146-2021-00646
• 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
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2023
• Device Model Number: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000138015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.; UNKNOWN.
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 98 KG