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

Catalog Number 0684-00-0497

Device Problems Difficult to Insert (1316); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2020

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.Complaint record id # (b)(4).

Event Description

It was reported that during insertion of an intra-aortic balloon (iab), the catheter was unable to pass through the sheath.Because of this, the balloon began to unfurl.Another iab was opened, but the same issue occurred.A third iab was opened and inserted successfully.This report is for the 2nd iab.There was no reported injury to the patient.

Manufacturer Narrative

Section d - suspect medical device serial number: (b)(6).Lot#: 3000112418.The product was returned with the membrane completely unfolded with blood on the exterior of the catheter.The one-way valve was also returned and still attached to the extracorporeal tubing.No physical damage observed.The returned one-way valve was tested and it held vacuum.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.A laboratory insertion test was unable to be performed due to the returned condition of the iab.The evaluation cannot confirm the reported problem due to the returned condition of the iab.We are unable to duplicate the clinical settings.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint #(b)(4).

Event Description

It was reported that during insertion of an intra-aortic balloon (iab), the catheter was unable to pass through the sheath.Because of this, the balloon began to unfurl.Another iab was opened, but the same issue occurred.A third iab was opened and inserted successfully.This report is for the 2nd iab.There was no reported injury to the patient.

Event Description

It was reported that during insertion of an intra-aortic balloon (iab), the catheter was unable to pass through the sheath.Because of this, the balloon began to unfurl.Another iab was opened, but the same issue occurred.A third iab was opened and inserted successfully.This report is for the 2nd iab.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).

• Brand Name: MEGA 8FR. 50CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 10063025
• MDR Text Key: 196846904
• Report Number: 2248146-2020-00255
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K091449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2023
• Device Catalogue Number: 0684-00-0497
• Device Lot Number: 3000112418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR