MAUDE Adverse Event Report: DATASCOPE FAIRFIELD TRANS-RAY PLUS 7.5 FR. 35CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0604

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Calcium Deposits/Calcification (1758); No Code Available (3191)

Event Date 02/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). 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

After intra-aortic balloon (iab) was inserted in an ami (acute myocardial infarction) patient an iab optical sensor failure occurred. Used inner lumen instead to continue therapy. Mild calcification, tortuosity and moderate sclerosis were noted in the patient vessel. The patient is in iab therapy continuously. No patient injury was reported.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the exterior of the catheter. Two kinks were found on the catheter tubing approximately 52. 8cm and 73. 2cm from the iab tip. The optical fiber was found to be broken at the kinked location of 52. 8cm. The optical fiber was found to be broken, confirming the reported alarm. 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. (b)(4).

Event Description

After intra-aortic balloon (iab) was inserted in an ami (acute myocardial infarction) patient an iab optical sensor failure occurred. Used inner lumen instead to continue therapy. Mild calcification, tortuosity and moderate sclerosis were noted in the patient vessel. The patient is in iab therapy continuously. No patient injury was reported.

• Brand Name: TRANS-RAY PLUS 7.5 FR. 35CC 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: 7356502
• MDR Text Key: 103287960
• Report Number: 2248146-2018-00183
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/18/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/14/2020
• Device Catalogue Number: 0684-00-0604
• Device Lot Number: 3000045454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: YR
• Event Location: No Information
• Date Manufacturer Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage