MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0567

Device Problems Backflow (1064); Leak/Splash (1354)

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

Event Date 03/04/2018

Event Type  malfunction  

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.(b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy the iab developed a leak; blood was seen in tubing.The iab was removed.There was no reported injury to the patient.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood found on the interior of the catheter and between the catheter and the sheath.The returned sheath was over the balloon membrane covering half of the membrane but it was not a maquet product.Two kinks were found, one on the catheter tubing approximately 76.5cm from the iab tip and another on the inner lumen approximately 21.8cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and three leaks were detected on the membrane approximately 23.1cm, 3.8cm and 3.6cm from the rear seal measuring 0.05cm and (2) 0.05cm in length.The optical fiber was found to be broken within the membrane approximately 24.4cm from the iab tip.The evaluation confirms the reported leak problem.The reported leaks were found on the membrane.Under magnification, a whitish patch was observed around the leaks.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.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).

Event Description

It was reported that during intra-aortic balloon (iab) therapy the iab developed a leak; blood was seen in tubing.The iab was removed.There was no reported injury to the patient.

Event Description

It was reported that during intra-aortic balloon (iab) therapy the iab developed a leak; blood was seen in tubing.The iab was removed.There was no reported injury to the patient.

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 7.5FR. 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: 7385498
• MDR Text Key: 104089785
• Report Number: 2248146-2018-00214
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K122628
• 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: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2020
• Device Catalogue Number: 0684-00-0567
• Device Lot Number: 3000063088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Device Age: YR
• Initial Date Manufacturer Received: 03/05/2018
• Initial Date FDA Received: 03/30/2018
• Supplement Dates Manufacturer Received: 04/02/2018; 04/24/2018
• Supplement Dates FDA Received: 04/24/2018; 05/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Weight: 128