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 Device Sensing Problem (2917); Optical Problem (3001); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/18/2019

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 intra-aortic balloon (iab) therapy, the nurse reported a loss of the arterial signal and a sensor failure alarm on the console.There was no external disruption of the fiber optic cable and the patient had not been moved.They did not have a pressure bag to the fluid lumen of the catheter and no other arterial line was available.The fluid lumen was capped.The nurse consulted with the physician on the floor who determined to remove the balloon instead of inserting a radial a few hours prior to the planned removal of the balloon in this stable patient.There was no reported injury to the patient.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the exterior of the catheter.Two kinks were located on the catheter approximately 48.3cm and 75.9cm from the iab tip.The optical fiber was found to be broken within the membrane approximately 24.4cm from the iab tip.The optical fiber was found to be broken, confirming the reported alarm.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.Reference complaint #(b)(4); reference id (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the nurse reported a loss of the arterial signal and a sensor failure alarm on the console.There was no external disruption of the fiber optic cable and the patient had not been moved.They did not have a pressure bag to the fluid lumen of the catheter and no other arterial line was available.The fluid lumen was capped.The nurse consulted with the physician on the floor who determined to remove the balloon instead of inserting a radial a few hours prior to the planned removal of the balloon in this stable patient.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: 8493081
• MDR Text Key: 141455428
• Report Number: 2248146-2019-00282
• 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: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2021
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000083945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Device Age: YR
• Date Manufacturer Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 87