MAUDE Adverse Event Report: DATASCOPE FAIRFIELD MEGA 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0497

Device Problems Device Alarm System (1012); No Display/Image (1183); Failure to Zero (1683); Pressure Problem (3012)

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

Event Date 11/23/2017

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

It was reported that a mega 50cc intra-aortic balloon catheter was used during intra-aortic balloon (iab) therapy due to heart failure.Before the connection to iab pump (iabp), blood was aspirated from the inner lumen for pressure monitoring set up.The zeroing of pressure line was normal at that time.After the iab was connected with the iabp, no arterial waveform was displayed.No alarm was detected at that moment as user was using auto mode (ecg signal was normal and used as triggering source).User found that no arterial waveform was shown so they recalibrated the pressure line.However, zeroing was unable to be performed while some numbers were displayed instead of "0".At the same time, they found that blood was unable to be aspirated from the inner lumen and suspected blood clot was formed.Finally iab was removed and inserted another one to continue the therapy.There was not patient injury reported.

Manufacturer Narrative

The iab was returned with the membrane completely unfolded.No blood was visible on the catheter.The technician was able to successfully aspirate/flush the inner lumen.The technician attempted to insert a laboratory 0.025¿ guide wire through the inner lumen and was able to successfully insert the guide wire.No obstructions were felt.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.An evaluation of the product was unable to duplicate the reported problem.The product performed according to specification.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 a mega 50cc intra-aortic balloon catheter was used during intra-aortic balloon (iab) therapy due to heart failure.Before the connection to iab pump (iabp), blood was aspirated from the inner lumen for pressure monitoring set up.The zeroing of pressure line was normal at that time.After the iab was connected with the iabp, no arterial waveform was displayed.No alarm was detected at that moment as user was using auto mode (ecg signal was normal and used as triggering source).User found that no arterial waveform was shown so they recalibrated the pressure line.However, zeroing was unable to be performed while some numbers were displayed instead of "0".At the same time, they found that blood was unable to be aspirated from the inner lumen and suspected blood clot was formed.Finally iab was removed and inserted another one to continue the therapy.There was not patient injury reported.

Manufacturer Narrative

'lot number' changed from: 3000050639 to: 3000045495.Complaint # (b)(4).

Event Description

It was reported that a mega 50cc intra-aortic balloon catheter was used during intra-aortic balloon (iab) therapy due to heart failure.Before the connection to iab pump (iabp), blood was aspirated from the inner lumen for pressure monitoring set up.The zeroing of pressure line was normal at that time.After the iab was connected with the iabp, no arterial waveform was displayed.No alarm was detected at that moment as user was using auto mode (ecg signal was normal and used as triggering source).User found that no arterial waveform was shown so they recalibrated the pressure line.However, zeroing was unable to be performed while some numbers were displayed instead of "0".At the same time, they found that blood was unable to be aspirated from the inner lumen and suspected blood clot was formed.Finally iab was removed and inserted another one to continue the therapy.There was not patient injury reported.

• Brand Name: MEGA 8FR. 50CC 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: 7135468
• MDR Text Key: 95794184
• Report Number: 2248146-2017-00727
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K091449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2020
• Device Catalogue Number: 0684-00-0497
• Device Lot Number: 3000045495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2017
• 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 Age: 46 YR
• Patient Weight: 55