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

Model Number 0684-00-0296-01

Device Problems Difficult to Flush (1251); Material Deformation (2976); Pressure Problem (3012)

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

Event Date 04/20/2021

Event Type  malfunction  

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.Complaint record id #(b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the waveform was dampened.The customer replaced the iab, but the same issue occurred.The customer was advised to re-zero and flush the iab.It was reported that both iabs were very difficult to flush.It was noted that there was a possibility of a severe kink which was causing the difficulty to flush.The customer was advised to try a different pressure cable and transducer.They were also notified that they could obtain a separate arterial line on the patient and attempt to transduce it to the console.There was no patient harm or adverse event reported.This report is for the second iab used in this event.A separate report will be submitted for the first iab used.

Manufacturer Narrative

Device evaluation: the product was returned with the membrane completely unfolded and traces of blood found on the exterior of the catheter and between the catheter and the sheath.The returned sheath was over the catheter and partially covering the rear portion of the balloon.The pressure tubing was also returned.A kink was found on catheter tubing approximately 41.7cm from the iab tip.Additionally a kink was found on catheter tubing and inner lumen near the y-fitting approximately 76.2cm from the iab tip.The technician attempted to flush/aspirate the inner lumen and was unable to do so.The technician then attempted to insert a 0.025¿ laboratory guide wire through the inner lumen and resistance was only felt at the kinked location.The condition of the iab as received indicated a kink on the catheter tubing and inner lumen.This can cause difficulty monitoring the waveform and flushing of the inner lumen.The evaluation confirmed the reported problems.We are unable to determine when the kinks 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).

Event Description

N/a.

• Brand Name: MEGA 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: 11798080
• MDR Text Key: 249728504
• Report Number: 2248146-2021-00303
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108001
• UDI-Public: 10607567108001
• Combination Product (y/n): N
• PMA/PMN Number: K091449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2023
• Device Model Number: 0684-00-0296-01
• Device Catalogue Number: 0684-00-0497
• Device Lot Number: 3000115474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Date Manufacturer Received: 07/29/2021
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 91