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

Catalog Number 0684-00-0514

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 11/22/2017

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.Complaint # (b)(4), record # (b)(4).

Event Description

It was reported that soon after intra-aortic balloon (iab) insertion on an ami patient, alarm ¿iab optical sensor failure¿ was generated.Replaced iab to continue therapy.No patient injury was reported.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and traces of blood on the exterior of the catheter.Dried blood was found occluding the inner lumen.The occlusion was unable to be cleared.A sensor output test was performed and a pressure reading could not be obtained.The technician then used an optical light to see if there were any breaks in the sensor's optical fiber and a break was observed within the orange sensor cable near the y-fitting.The optical fiber was found to be broken, confirming the reported alarm, iab optical sensor failure problem.We are unable to determine when this may have occurred.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); record # (b)(4).

Event Description

It was reported that soon after intra-aortic balloon (iab) insertion on an ami(acute myocardial infarction) patient, alarm ¿iab optical sensor failure¿ was generated.Replaced iab to continue therapy.No patient injury was reported.

• Brand Name: TRANS-RAY 7FR. 40CC IAB - JAPAN
• 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: 7145225
• MDR Text Key: 95827919
• Report Number: 2248146-2017-00735
• 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,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2019
• Device Catalogue Number: 0684-00-0514
• Device Lot Number: 3000041412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2016
• 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