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

Catalog Number 0684-00-0575

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2019

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 during insertion of the intra-aortic balloon (iab), it was difficult to insert the balloon through the sheath.The balloon was replaced to start therapy.There was no reported injury to the patient.

Manufacturer Narrative

The product was returned with the membrane completely folded with traces of blood on the exterior of the catheter.The one-way valve was also returned and still attached to the extracorporeal tubing.Additionally, one (1) kink was observed on the catheter closest to the y-fitting at approximately 76.4cm from the iab tip.The one-way valve was vacuum tested and it held vacuum.A laboratory insertion test was unable to be performed due to the returned condition of the iab.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal, extender and pressure tubing was performed and no leaks were detected.We are unable to confirm the reported problem due to the returned condition of the iab since we are unable to mimic the clinical settings.Reference complaint #(b)(4).

Event Description

It was reported that during insertion of the intra-aortic balloon (iab), it was difficult to insert the balloon through the sheath.The balloon was replaced to start therapy.There was no reported injury to the patient.

• 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: 8887287
• MDR Text Key: 154116769
• Report Number: 2248146-2019-00663
• 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: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2022
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000095708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1