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 Material Deformation (2976); Optical Problem (3001)

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

Event Date 04/02/2021

Event Type  malfunction  

Manufacturer Narrative

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 during intra-aortic balloon (iab) therapy the patient had lifted their knee and the console generated a fiber optic sensor failure alarm.There was no external kinking of the fiber optic cable, though, the customer noted that it had previously been kinked.The customer was advised to convert the arterial signal to the transducer/ fluid lumen.The image was crisp and the pressure indices were identical to the ones received through the fiber optic prior to the issue occurring.There was no patient harm or adverse event reported.

Manufacturer Narrative

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).

Event Description

It was reported that during intra-aortic balloon (iab) therapy the patient had lifted their knee and the console generated a fiber optic sensor failure alarm.There was no external kinking of the fiber optic cable, though, the customer noted that it had previously been kinked.The customer was advised to convert the arterial signal to the transducer/ fluid lumen.The image was crisp and the pressure indices were identical to the ones received through the fiber optic prior to the issue occurring.There was no patient harm or adverse event reported.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the exterior of the catheter.The extender tubing was also returned.A kink was found on the catheter tubing and inner lumen approximately 75.2cm from the iab tip.Additionally a second kink was found on the catheter tubing approximately 59.9cm from the iab tip.The optical fiber was found to broken within the catheter tubing approximately 72.9cm from iab tip.The condition of the iab as received indicated kinks on the catheter tubing and inner lumen and the optical fiber found to be broken confirming the reported problems.We are unable to determine when this 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.The device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.The review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.The overall complaint trend data for the period may-19 to apr-21 was reviewed.There were no triggers identified for the review period.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
• MDR Report Key: 11706005
• MDR Text Key: 246699659
• Report Number: 2248146-2021-00249
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: 10607567108605
• Combination Product (y/n): N
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2023
• Device Model Number: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 30001311351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Date Manufacturer Received: 07/20/2021
• Patient Sequence Number: 1
• Treatment: CS300; CS300
• Patient Age: 70 YR
• Patient Weight: 98