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

Catalog Number 0684-00-0575

Device Problems Display or Visual Feedback Problem (1184); Failure to Calibrate (2440)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2018

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 the intra-aortic balloon was inserted through the axillary insertion site, which is off-label use.The iab was unable to calibrate and there was a fiber optic sensor alarm generated.The pressure was reported to read high for systolic, low for diastolic, and the augmentation seemed high.The customer attempted to troubleshoot the issue, but was unsuccessful.The customer switched to central lumen via transducer to monitor pressure.The reading did not improve.However the patient was re-positioned which improved pressures.There was no reported injury to the patient.

Event Description

It was reported that the intra-aortic balloon was inserted through the axillary insertion site, which is off-label use.The iab was unable to calibrate and there was a fiber optic sensor alarm generated.The pressure was reported to read high for systolic, low for diastolic, and the augmentation seemed high.The customer attempted to troubleshoot the issue, but was unsuccessful.The customer switched to central lumen via transducer to monitor pressure.The reading did not improve.However the patient was re-positioned which improved pressures.There was no reported injury to the patient.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the interior of the catheter.One kink was observed on the catheter tubing approximately 67.8cm from iab tip.The optical fiber was found to be broken at the kinked location.The optical fiber was found to be broken, confirming the reported problems.We are unable to determine when this may have occurred.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.(b)(4).

• Brand Name: SENSATION PLUS 8FR. 50CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 8130073
• MDR Text Key: 129351897
• Report Number: 2248146-2018-00700
• 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: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2021
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000080686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Device Age: YR
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 66