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

Catalog Number 0684-00-0575

Device Problems Difficult to Flush (1251); Off-Label Use (1494)

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

Event Date 05/11/2021

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 console and iab were functioning well and displayed a clear and crisp arterial line.The central lumen of the iab was transduced to the bedside monitor and was displaying a dampened waveform.The insertion was reported to be axillary, which is not the method described in the device instructions for use.The customer was able to aspirate a small amount of blood via the central lumen and described the flush as difficult.A 15-second flush did improve the arterial line and the issue was resolved.There was no patient harm or adverse event reported.

Event Description

N/a.

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).

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter.The extender and pressure tubing were also returned.Five kinks were found on the catheter tubing and inner lumen approximately 54.9cm, 56.1cm, 56.9cm, 72.9cm and 76.5cm from the iab tip.A penetration was observed at this location of 76.5cm.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal, extender and pressure tubing was performed and a leak was confirmed on the inner lumen and catheter tubing.The penetration found in the catheter tubing appears to have been caused by a severe kink flexing back and forth that eventually penetrated the tubing causing the reported problem.The insertion was reported to be axillary, which is not the method described in the device instructions for use.This may have contributed to the iab failure.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 (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 jun-19 to may-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
• MDR Report Key: 11922771
• MDR Text Key: 253810401
• Report Number: 2248146-2021-00350
• Device Sequence Number: 1
• Product Code: DSP
• 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: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2023
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000132558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Date Manufacturer Received: 08/06/2021
• Patient Sequence Number: 1
• Treatment: CS300 / SI201281J1; CS300 / SI201281J1.
• Patient Age: 59 YR
• Patient Weight: 112