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

Catalog Number 0684-00-0567

Device Problem Defective Component (2292)

Patient Problem Thrombus (2101)

Event Date 12/23/2018

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 and fiber optic cable reconnection did not fix the problem.A chest x-ray (cxr) verified placement and it was noted by the customer that the central lumen was clotted.There was no reported injury to the patient.

Event Description

It was reported that during intra-aortic balloon (iab) therapy there was a fiber-optic sensor failure and fiber optic cable reconnection did not fix the problem.A chest x-ray (cxr) verified placement and it was noted by the customer that the central lumen was clotted.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 sheath was returned covering the proximal end of the membrane by a taper only.One kink was observed on the catheter tubing approximately 37.6cm from the iab tip.The optical fiber was found to be broken within the membrane near the rear seal approximately 23.6cm from the iab tip.- the technician attempted to flush/aspirate the inner lumen and was unable to do so.- the technician then attempted to insert a laboratory 0.025¿ guide wire through the inner lumen of the returned iab and found that the inner lumen was occluded.The technician was unable to clear the occlusion.The condition of the iab as received indicated an optical fiber break and an occlusion in the inner lumen.The evaluation confirmed the reported problems.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.(b)(4).

• Brand Name: SENSATION PLUS 7.5FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 8245493
• MDR Text Key: 133202104
• Report Number: 2248146-2019-00025
• 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
• Report Date: 03/14/2019

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: 05/31/2021
• Device Catalogue Number: 0684-00-0567
• Device Lot Number: 3000073441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Device Age: YR
• Initial Date Manufacturer Received: 12/23/2018
• Initial Date FDA Received: 01/14/2019
• Supplement Dates Manufacturer Received: 02/22/2019
• Supplement Dates FDA Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 55