MAUDE Adverse Event Report: DATASCOPE FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0605

Device Problems Backflow (1064); Failure to Pump (1502)

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

Event Date 12/21/2017

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, an intra-aortic balloon (iab) was inserted on an ami patient.Therapy could not be initiated as iab did not begin pumping.Blood back run was noted.The customer assumes there was an iab rupture.Replaced iab to continue therapy.No patient injury was reported.

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 on 21/dec/2017, an intra-aortic balloon (iab) was inserted on an ami (acute myocardial infarction) patient.Therapy could not be initiated as iab did not begin pumping.Blood back run was noted.The customer assumes there was an iab rupture.Replaced iab to continue therapy.No patient injury was reported.

Manufacturer Narrative

Correction: report source should have excluded distributor in the original mdr.Submission device evaluation: the product was returned with the membrane completely unfolded and blood found on the exterior of the catheter.The one-way valve was also returned.Dried blood was found occluding the inner lumen.The occlusion was unable to be cleared.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The iab was placed on the cs300 pump and the iab fully inflated.No alarm sounded from the pump.The reported difficult/unable to inflate event cannot be confirmed by the evaluation.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 (b)(6) 2017, an intra-aortic balloon (iab) was inserted on an ami (acute myocardial infarction) patient.Therapy could not be initiated as iab did not begin pumping.Blood back run was noted.The customer assumes there was an iab rupture.Replaced iab to continue therapy.No patient injury was reported.

• Brand Name: TRANS-RAY PLUS 7.5 FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 7199848
• MDR Text Key: 97921438
• Report Number: 2248146-2018-00028
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2019
• Device Catalogue Number: 0684-00-0605
• Device Lot Number: 3000040301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Device Age: YR
• Date Manufacturer Received: 02/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 59