MAUDE Adverse Event Report: DATASCOPE FAIRFIELD MEGA 7.5FR. 30CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0292

Device Problem Backflow (1064)

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

Event Date 11/30/2017

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.(b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy there was blood noted in the gas line.There was no reported injury to the patient.

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 # (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy there was blood noted in the gas line.There was no reported injury to the patient.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter.The extracorporeal tubing was cut from the iab and not returned.A visual examination of the product detected the inner lumen within the catheter tubing near the y-fitting was completely separated within a kink approximately 76.7cm from iab tip.An underwater leak test of the balloon, catheter and y-fitting was performed and one additional leak was found on the catheter tubing 47.8cm from the iab tip.The break found in the inner lumen appears to have been the result of a severe kink, which eventually failed and allowed blood to leak into the membrane and catheter tubing causing the reported problem.It is difficult to determine when the break occurred but it is possibly a result of patient movement during the procedure.The evaluation confirmed the reported problem.Continual flexing of a kink can cause the catheter to become penetrated.It is difficult to determine when the penetration may have occurred, however, it could cause the reported event.The penetration found in the catheter tubing appears to have been caused by a sharp object.This may have occurred during iab removal from the patient.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).

Event Description

It was reported that during intra-aortic balloon (iab) therapy there was blood noted in the gas line.The indication for use was a bridge to transplant.There was no reported injury to the patient.

• Brand Name: MEGA 7.5FR. 30CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 7144853
• MDR Text Key: 95905709
• Report Number: 2248146-2017-00731
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2018

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: 08/25/2020
• Device Catalogue Number: 0684-00-0292
• Device Lot Number: 30000576840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 01/31/2018; 02/23/2018
• Supplement Dates FDA Received: 02/21/2018; 03/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 65