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 Problems Difficult to Flush (1251); Optical Problem (3001)

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

Event Date 09/20/2021

Event Type  malfunction  

Manufacturer Narrative

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).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, a fiber optic sensor failure occurred.The central lumen was also clotted and the iab could not aspirate or flush.There was no other arterial line available.The customer was advised to consider obtaining another arterial line for the pressure waveform.They did have the correct pressure cable and planned to call the physician for further assistance.At this point, the console was pumping and the patient was stable.There was no patient harm or adverse event reported.

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 maquet sheath.The extender tubing and non-maquet pressure tubing were also returned.An optical fiber break was observed within the membrane at approximately 26.2cm from the iab tip.An underwater leak test of the balloon, catheter tubing, y-fitting, extracorporeal tubing and extender tubing was performed and no leaks were detected.A 0.025¿ laboratory guidewire was inserted through the inner lumen and was found to be occluded with dry blood.Unable to clear the occlusion.The inner lumen was found occluded and the optical fiber was found to be broken, confirming the reported problem.However, we are unable to determine when these failures may have occurred.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 (3331/213) - 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 (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period sep-19 through aug-21 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.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: 12624062
• MDR Text Key: 276153429
• Report Number: 2248146-2021-00661
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2023
• Device Model Number: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000138155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 10/13/2021
• Supplement Dates Manufacturer Received: 11/11/2021
• Supplement Dates FDA Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARDIOSAVE; CARDIOSAVE
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 78 KG