MAUDE Adverse Event Report: DATASCOPE FAIRFIELD TRANS-RAY 7FR. 40CC IAB - JAPAN; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0513

Device Problem Failure to Advance (2524)

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

Event Date 03/30/2018

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 during intra-aortic balloon (iab) insertion in ami(acute myocardial infarction) patient that the iab catheter was unable to advance through the sheath.The iab was replaced to continue therapy.There was no patient injury was reported.

Manufacturer Narrative

Correction: lot # changed from: 3000043012 to:3000041412.Serial # added.Expiration date changed from: 01/03/2020 to:12/05/2019.Describe event or problem: removed "was".Manufacture date changed from: 01/03/2017 to: 12/05/2016.Device evaluation: the product was returned with the membrane completely unfolded and traces of blood found on the exterior of the catheter with the one-way valve attached.The guide wire was also returned.The sheath was not returned for evaluation.The returned guide wire was found to be bent in two places near the proximal end and could not be used for testing.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, extracorporeal and extender 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 non-conformances were found that are considered to be related to the event.(b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) insertion in ami (acute myocardial infarction) patient that the iab catheter was unable to advance through the sheath.The iab was replaced to continue therapy.There was no patient injury reported.

• Brand Name: TRANS-RAY 7FR. 40CC IAB - JAPAN
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 7471648
• MDR Text Key: 106973535
• Report Number: 2248146-2018-00285
• 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
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2019
• Device Catalogue Number: 0684-00-0513
• Device Lot Number: 3000041412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Device Age: YR
• Date Manufacturer Received: 04/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1