MAUDE Adverse Event Report: DATASCOPE FAIRFIELD YAMATO PLUS-R 7.5FR. 30CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0549-01

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Calcium Deposits/Calcification (1758); Myocardial Infarction (1969)

Event Date 12/27/2017

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.(b)(4).

Event Description

It was reported that on (b)(6) 2017, intra-aortic balloon (iab) therapy was initiated on an acute myocardial infarction (ami) patient.On (b)(6) 2017 in icu blood back run was noted.There was an alarm generated, but was unspecified by the customer.Moderate tortuosity and calcification were noted in the patient vessel.Replaced iab to continue iab therapy.No patient injury was reported.

Manufacturer Narrative

Device evaluation: the product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter and between the catheter and the sheath.The returned sheath was covering more than half of the balloon membrane but it was a competitor product.The returned inner lumen within the membrane was observed to be coiled.A visual examination of the product detected the inner lumen within the membrane was completely separated within a kink approximately 9.4cm from iab tip.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no other leaks were detected.The evaluation confirmed the reported alarm, unknown & leak, blood in tubing problem.The break found in the inner lumen appears to have been the result of a severe kink, which eventually failed and allowed blood to leak into the membrane and catheter tubing causing the reported alarm, unknown and blood in tubing problems.It is difficult to determine when the break occurred but it is possibly a result of patient movement during the procedure.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

It was reported that on 26/dec/2017, intra-aortic balloon (iab) therapy was initiated on an acute myocardial infarction (ami) patient.On (b)(6) 2017 in intensive care unit (icu) blood back run was noted.There was an alarm generated, but was unspecified by the customer.Moderate tortuosity and calcification were noted in the patient vessel.Replaced iab to continue iab therapy.No patient injury was reported.

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

It was reported that on 26/dec/2017, intra-aortic balloon (iab) therapy was initiated on an acute myocardial infarction (ami) patient.On (b)(6) 2017 in icu blood back run was noted.There was an alarm generated, but was unspecified by the customer.Moderate tortuosity and calcification were noted in the patient vessel.Replaced iab to continue iab therapy.No patient injury was reported.

• Brand Name: YAMATO PLUS-R 7.5FR. 30CC 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: 7211853
• MDR Text Key: 98199587
• Report Number: 2248146-2018-00041
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2018

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: 06/27/2020
• Device Catalogue Number: 0684-00-0549-01
• Device Lot Number: 3000054412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 12/28/2017
• Initial Date FDA Received: 01/23/2018
• Supplement Dates Manufacturer Received: 02/09/2018; 02/26/2018
• Supplement Dates FDA Received: 02/27/2018; 03/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2017
• 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: 66 YR
• Patient Weight: 50