MAUDE Adverse Event Report: DATASCOPE FAIRFIELD TRANS-RAY PLUS 7.5 FR. 35CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0604

Device Problems Failure to Advance (2524); Material Deformation (2976)

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

Event Date 07/07/2018

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 the physician encountered difficulty advancing the intra-aortic balloon (iab) through the sheath during insertion for an acute myocardial infarction (ami) patient.A kink was noted after the attempt.Replaced iab to continue therapy.No patient injury reported.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the exterior of the catheter with the one-way valve attached upside down.The sheath was not returned for evaluation.The one-way valve was vacuum tested and it held vacuum.A laboratory insertion test was unable to be performed due to the membrane being unfurled.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.A leak may impact the ability to maintain vacuum.We are unable to confirm the reported difficulty during insertion because of the returned condition of the catheter and we are unable to mimic the clinical setting.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 nonconformances were found that are considered to be related to the event.(b)(4).

Event Description

It was reported that the physician encountered difficulty advancing the intra-aortic balloon (iab) through the sheath during insertion for an acute myocardial infarction (ami) patient.A kink was noted after the attempt.Replaced iab to continue therapy.No patient injury reported.

Manufacturer Narrative

Correction: the original emdr submission should have reflected the part return.Section d.10.Should have reflected the "returned to manufacture on" date of 08/01/2018.Section h.6 evaluation result code should have reflected code 3233.Evaluation conclusion code should have reflected code 11.Evaluation method code should not have included code 4114.Section h.10 should have had statement indicating product was returned.Complaint # (b)(4).

Event Description

It was reported that the physician encountered difficulty advancing the intra-aortic balloon (iab) through the sheath during insertion for an acute myocardial infarction (ami) patient.A kink was noted after the attempt.Replaced iab to continue therapy.No patient injury reported.

• Brand Name: TRANS-RAY PLUS 7.5 FR. 35CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 7747199
• MDR Text Key: 116238291
• Report Number: 2248146-2018-00471
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2021
• Device Catalogue Number: 0684-00-0604
• Device Lot Number: 3000070482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Device Age: YR
• Date Manufacturer Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1