MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0434

Device Problem Failure to Calibrate (2440)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 that the fiber optic sensor failed to calibrate.There was no reported injury to the patient.The date of the event is unknown.

Event Description

It was reported that during intra-aortic balloon (iab) therapy that the fiber optic sensor failed to calibrate.There was no reported injury to the patient.The date of the event is unknown.Additional information from customer: it was reported that a patient that underwent aortic valve replacement, bentall procedure, and other unspecified procedures had an intra-aortic balloon (iab) placed while trying to transition the patient from the heart lung machine.The iab pump machine indicated the optic sensor was not calibrated.After many attempts to fix the optic sensor and switching machines and calling the manufacturer's rep the surgeon inserted a new iab.While trouble shooting balloon pump, patient was put back on heart lung machine and a cabg (coronary artery bypass graft) was performed.After the cabg was done a new balloon was placed.The second iab was inserted in the existing opening and there was a leak around the femoral artery that could not be controlled.It was then taken out because of the leaking around incision site.A new 3rd balloon was placed in the right femoral artery through groin to fix the leak.The last known status of patient was a plan to discharge as of (b)(6) 2018.This submission is for the 1st iab used which was reported to have fiber optic failure.Reference mdr 2248146-2018-00266, (b)(4) submitted for the second iab.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the exterior of the catheter.The extender tubing was also returned.One kink was found on the catheter tubing near the y-fitting approximately 76.2cm from the iab tip.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 extender tubing was performed and no leaks were detected.An evaluation of the product was unable to duplicate the reported problem.The product performed according to specification.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.(b)(4).

• Brand Name: SENSATION 7FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 7352115
• MDR Text Key: 103065372
• Report Number: 2248146-2018-00177
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• 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: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2020
• Device Catalogue Number: 0684-00-0434
• Device Lot Number: 3000062644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Device Age: YR
• Date Manufacturer Received: 03/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 75