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

Catalog Number 0684-00-0434

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 12/08/2017

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 there was a fiber optic sensor failure alarm generated.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 and between the catheter and the sheath.The returned sheath was over the catheter but it was not a maquet product.The extension tubing was also returned.Four kinks were observed on the catheter tubing approximately 52.1cm, 52.6cm, 52.8cm and 76.2cm from the iab tip.The optical fiber was also found to be broken at this location.The optical fiber was found to be broken, confirming the reported problems.The evaluation confirmed the reported problem.It is difficult to determine when or how a break in the fiber optic occurs.However, a kink in the catheter can cause the fiber optic to break resulting in no signal or the inability to calibrate it.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.Complaint # (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy there was a fiber optic sensor failure alarm generated.There was no reported injury to the patient.

• 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
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 7154850
• MDR Text Key: 96230283
• Report Number: 2248146-2017-00753
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2020
• Device Catalogue Number: 0684-00-0434
• Device Lot Number: 3000056315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 100