MAUDE Adverse Event Report: DATASCOPE FAIRFIELD TRANS-RAY 7FR. 34CC IAB - JAPAN; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0513

Device Problems Device Displays Incorrect Message (2591); Calibration Problem (2890)

Patient Problems Calcium Deposits/Calcification (1758); Unspecified Infection (1930)

Event Date 08/28/2017

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.(b)(4).

Event Description

After intra-aortic balloon (iab) iab insertion on myocarditis patient.Calibration was not possible due to iab optical sensor alarm.The iab was replaced to continue therapy.There was no injury or harm to the patient.Mild sclerosis, calcification and severe tortuosity were noted in the patient vessel.

Manufacturer Narrative

10/06/2017 (b)(4): the product was returned with the membrane completely unfolded and blood on the exterior of the catheter.The extender tubing was also returned.One kink was found on the catheter tubing near the y-fitting approximately 76.2cm from the iab tip.The inner lumen was found to be occluded with dried blood.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 y-fitting.T the optical fiber was found to be broken, confirming the reported problem.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.Complaint # (b)(4); record # (b)(4).

Event Description

After intra-aortic balloon (iab) iab insertion on myocarditis patient.Calibration was not possible due to iab optical sensor alarm.The iab was replaced to continue therapy.There was no injury or harm to the patient.Mild sclerosis, calcification and severe tortuosity were noted in the patient vessel.

• Brand Name: TRANS-RAY 7FR. 34CC 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: 6872382
• MDR Text Key: 87345239
• Report Number: 2248146-2017-00394
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/17/2019
• Device Catalogue Number: 0684-00-0513
• Device Lot Number: 3000035332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2016
• 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
• Patient Weight: 52