MAUDE Adverse Event Report: DATASCOPE FAIRFIELD TRANS-RAY PLUS 7.5 FR. 35CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0604

Device Problems Kinked (1339); Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/07/2018

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.(b)(4).

Event Description

It was reported during intra-aortic balloon (iab) insertion on an ami(acute myocardial infarction) patient that although insertion was a bit difficult to advance, it was used normally.During procedure unusual waveform was seemed on the monitor indicating a kink.Replaced iab to continue therapy.No patient injury was reported.

Event Description

It was reported during intra-aortic balloon (iab) insertion on an ami(acute myocardial infarction) patient that although insertion was a bit difficult to advance, it was used normally.During procedure unusual waveform was seemed on the monitor indicating a kink.Replaced iab to continue therapy.No patient injury was reported.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood found on the exterior of the catheter.The sheath was not returned for evaluation.One kink was found on catheter tubing/inner lumen near the y-fitting approximately 76.2cm from the iab tip.The technician attempted to insert a 0.025¿ laboratory guide wire through the inner lumen and resistance was only felt at the kinked location.A laboratory insertion test was unable to be performed due to the membrane being unfurled.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.A leak may impact the ability to maintain vacuum.The condition of the iab as received indicated a kink on the inner lumen and catheter tubing.The evaluation confirmed the reported kink and difficulty to monitor waveform.A kink can cause poor or no pressure waveform.We are unable to conclusively determine when the kink may have occurred.We are unable to confirm the reported difficulty during insertion because of the returned condition of the catheter and we are unable to mimic the clinical setting.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.Complaint # (b)(4), record # (b)(4).

• Brand Name: TRANS-RAY PLUS 7.5 FR. 35CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 7352851
• MDR Text Key: 103035425
• Report Number: 2248146-2018-00179
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2019
• Device Catalogue Number: 0684-00-0604
• Device Lot Number: 3000038474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Device Age: YR
• Date Manufacturer Received: 03/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1