MAUDE Adverse Event Report: DATASCOPE FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0474

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 08/11/2017

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 during insertion of the intra-aortic balloon (iab), the balloon could not be inserted.The physician removed the iab and replaced it with a new iab.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the exterior of the catheter.The guide wire was also returned stuck inside the inner lumen due to dried blood.When removing the wire it became unraveled and could not be used for testing.The inner lumen was found to be occluded with dried blood.The occlusion was able to be cleared.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 non-conformances were found that are considered to be related to the event.(b)(4).

Event Description

It was reported that during insertion of the intra-aortic balloon (iab), the balloon could not be inserted.The physician removed the iab and replaced it with a new iab.

• Brand Name: LINEAR 7.5 FR. 34CC 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: 6868926
• MDR Text Key: 86612130
• Report Number: 2248146-2017-00390
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/17/2020
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000049486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2017
• 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: 63 YR
• Patient Weight: 55