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 Device Alarm System (1012); Defective Component (2292)

Patient Problems Angina (1710); Death (1802)

Event Date 09/10/2017

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 that on (b)(6) 2017 intra-aortic balloon (iab) was used on angina pectoris patient in emergency.Defective expansion of balloon occurred during procedure continuously.Iab was used continuously.No alarm was generated.Surgery was ended with no adverse event on a patient.Removed iab and discontinued therapy.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood 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.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and pressure tubing was performed and no leaks were detected.The iab was placed on the cs300 pump and the iab fully inflated.No alarm sounded from the pump.An evaluation of the product was unable to duplicate the reported problem.The product performed according to specification.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.(b)(4).

Event Description

It was reported that on (b)(6) 2017 intra-aortic balloon (iab) was used on angina pectoris patient in emergency.Defective expansion of balloon occurred during procedure continuously.Iab was used continuously.No alarm was generated.Surgery was ended with no adverse event on a patient.Removed iab and discontinued therapy.

• 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
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 6912544
• MDR Text Key: 88102770
• Report Number: 2248146-2017-00436
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/21/2019
• Device Catalogue Number: 0684-00-0604
• Device Lot Number: 3000036895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2016
• 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