MAUDE Adverse Event Report: DATASCOPE FAIRFIELD; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0575

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 06/25/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).The product was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath.The extension tubing was also returned.A sensor output test was performed and the sensor was found to be within specification.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extension tubing was performed and no leaks were detected.The reported event cannot be confirmed by the evaluation.A device and lot history record review and trend evaluation was completed for the reported product.No nonconformances were found that are considered to be related to the event.(b)(4).

Event Description

I spoke to (b)(6), rn in the cath lab, they just put in a sensation plus 50 sn# (b)(4) and getting an iab optical sensor failure/ switched pumps and getting the same message.I instructed her to unplug the fiber optic cable and transducer the inner lumen for the arterial line and reminded her they would have to level and zero.No harm was done to the patient.Gender male/ (b)(6).The patient was being transferred to icu and i spoke to (b)(6), rn and instructed her to save the iab in a biohazard bag when the dr.(b)(6) pulled it and we would send a return (b)(6) box to (b)(6), manager of the icu.Email (b)(6).Maquet aware of patient being deceased during evaluation of device on (b)(6) 2016.Facility intake form was returned with product.The death was not attributed to the device per the facility.Iab storage archive # (b)(4).

• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 5934646
• MDR Text Key: 54138326
• Report Number: 2248146-2016-00073
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/03/2019
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000025261
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2016
• Initial Date FDA Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 61 YR