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 Reflux within Device (1522); Device Contamination with Body Fluid (2317)

Patient Problem No Code Available (3191)

Event Date 08/12/2016

Event Type  malfunction  

Manufacturer Narrative

Date was not entered in the initial mdr. Manufacturer date: 08/12/2016.

Event Description

Shortly after a bedside insertion the staff reported seeing blood in the helium tubing. Dr. (b)(6) denied difficulty on insertion due to the act levels being elevated. The resistance was extreme and a surgical removal was arranged when the act declined.

Manufacturer Narrative

The device has not been returned to the manufacturer and we're unable to complete an evaluation on the affected product. When its' provided we will send a supplemental report with additional findings. We continue in our efforts to follow up with the customer for its' return. (b)(4).

Event Description

Shortly after a bedside insertion the staff reported seeing blood in the helium tubing. Dr. (b)(6) denied difficulty on insertion due to the act levels being elevated. The resistance was extreme and a surgical removal was arranged when the act declined.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter and between the catheter and the sheath. One kink was found on the catheter tubing approximately 34. 3cm from the iab tip. An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extension tubing was performed and one leak was detected on the membrane approximately 1. 5cm from the rear seal measuring 0. 038cm in length. The reported problem was most likely triggered by a leak which was found on the membrane. Under magnification, a whitish patch was observed around the leak. This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta. Complaint # (b)(4). Supplement - device evaluation.

Event Description

Shortly after a bedside insertion the staff reported seeing blood in the helium tubing. Dr (b)(6) denied difficulty on insertion due to the act levels being elevated. The resistance was extreme and a surgical removal was arranged when the act declined.

• 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
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 5906744
• MDR Text Key: 269739774
• Report Number: 2248146-2016-00070
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/21/2019
• Device Catalogue Number: 0684-00-0567
• Device Lot Number: 3000026131
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 08/26/2016 Patient Sequence Number: 1