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

Catalog Number 0684-00-0575

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Stroke/CVA (1770)

Event Date 08/03/2018

Event Type  Injury  

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 # (b)(4), record # (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy there was a "blood in tubing" alarm generated and blood was noted in the tubing.At the time of the event the patient was asleep in a recliner and the iab pump (iab) was in standby mode.The physician was notified and the patient was placed back in bed.Initially the patient was unresponsive so the staff intubated him and a stroke alert was called.The physician disconnected the iabp at the bed side.The patient was taken for ct (computed tomography) scan.An eeg (electroencephalogram) was completed at the patient's bedside.The patient is on a ventilator, but is able to open their eyes and squeeze with left hand.However, the patient is unable to move bilateral lower extremities and right arm as well as right hand.

Manufacturer Narrative

The reported brand name and catalog #.Changed from catalog # 0684-00-0497 brand name mega 8fr.50cc iab to brand name sensation plus 8fr.50cc iab catalog # 0684-00-0575.Correction was made from malfunction to serious injury.Correction was made pma/510(k)# changed from k091449 to k112327.The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter.The extender tubing and non maquet saline bag with tubing were also returned.The sheath seal was in place but the left and right wings were cut from the seal and not returned.Two kinks were found on the inner lumen within the membrane approximately 4.8cm and 13.2cm from the iab tip.Two kinks were found on the catheter tubing approximately 30cm and 76.2cm from the iab tip.The optical fiber was found to be broken at the kinked location of 76.2cm near the y-fitting.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and a leak was found that penetrated catheter tubing and inner lumen approximately 30cm from the iab tip.The penetration found appears to have been caused by a sharp object that penetrated through the catheter tubing and inner lumen.Though we are unable to determine when the penetration may have occurred, it is likely that it caused the reported problems.The evaluation confirms the reported problems.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).

Event Description

It was reported that during intra-aortic balloon (iab) therapy there was a "blood in tubing" alarm generated and blood was noted in the tubing.At the time of the event the patient was asleep in a recliner and the iab pump (iab) was in standby mode.The physician was notified and the patient was placed back in bed.Initially the patient was unresponsive so the staff intubated him and a stroke alert was called.The physician disconnected the iabp at the bed side.The patient was taken for ct (computed tomography) scan.An eeg (electroencephalogram) was completed at the patient's bedside.The patient is on a ventilator, but is able to open their eyes and squeeze with left hand.However, the patient is unable to move bilateral lower extremities and right arm as well as right hand.

Event Description

It was reported that during intra-aortic balloon (iab) therapy there was a "blood in tubing" alarm generated and blood was noted in the tubing.At the time of the event the patient was asleep in a recliner and the iab pump (iab) was in standby mode.The physician was notified and the patient was placed back in bed.Initially the patient was unresponsive so the staff intubated him and a stroke alert was called.The physician disconnected the iabp at the bed side.The patient was taken for ct (computed tomography) scan.An eeg (electroencephalogram) was completed at the patient's bedside.The patient is on a ventilator, but is able to open their eyes and squeeze with left hand.However, the patient is unable to move bilateral lower extremities and right arm as well as right hand.

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).

• 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: 7808419
• MDR Text Key: 118247763
• Report Number: 2248146-2018-00516
• 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,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2021
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000066273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Device Age: YR
• Date Manufacturer Received: 09/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 79