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 Leak/Splash (1354); Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 console generated a catheter restriction alarm and blood was seen in the tubing.The catheter was removed.There was no patient injury reported.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter.The catheter was cut near the rear seal approximately 24.1cm from the iab tip.The catheter tubing, y-fitting, and extracorporeal tubing were not returned for evaluation.Three extender tubes were returned connected together.An underwater leak test of the membrane and the three extender tubes were performed and no leaks were detected.Due to the returned condition of the catheter we are unable to confirm the reported leak and alarm.The dhr and lhr review is not able to be performed since the product info was not provided.Reference complaint # (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy , the console generated a catheter restriction alarm and blood was seen in the tubing.The catheter was removed.There was no patient injury reported.

• 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 07004
• MDR Report Key: 8824003
• MDR Text Key: 186145148
• Report Number: 2248146-2019-00631
• 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
• Report Date: 09/20/2019

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 Catalogue Number: 0684-00-0575
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/09/2019
• Initial Date FDA Received: 07/24/2019
• Supplement Dates Manufacturer Received: 09/10/2019
• Supplement Dates FDA Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 71