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

Catalog Number 0684-00-0434

Device Problems Difficult to Insert (1316); Uncoiled (1659); Physical Resistance (2578)

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

Event Date 02/01/2018

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 intra-aortic balloon (iab) insertion that the iab could not be inserted.The customer states there was a lot of resistance and balloon became unfurled.After was inserted it was unable to inflate.A new iab was inserted.The indication for use was cardiogenic shock and high risk pci (percutaneous coronary intervention).There was no reported injury to the patient.

Event Description

It was reported that during intra-aortic balloon (iab) insertion that the iab could not be inserted.The customer states there was a lot of resistance and balloon became unfurled.After was inserted it was unable to inflate.A new iab was inserted.The indication for use was cardiogenic shock and high risk pci (percutaneous coronary intervention).There was no reported injury to the patient.

Manufacturer Narrative

Additional information: added 510k #.Device evaluation: the product was returned with the membrane loosely folded and blood found on the exterior of the catheter with the one-way valve attached.The stylet wire was also returned.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.The technician attempted to insert the returned 0.018¿ guide wire through the inner lumen and was able to successfully insert the guide wire.No obstructions were felt.The iab was placed on the cs300 pump and the iab fully inflated.No alarm sounded from the pump.We are unable to confirm the reported difficult/unable to insert & unfurled membrane & difficult/unable to inflate and we are unable to mimic the clinical setting.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).

• Brand Name: SENSATION 7FR. 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: 7301941
• MDR Text Key: 101253875
• Report Number: 2248146-2018-00122
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• 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: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2020
• Device Catalogue Number: 0684-00-0434
• Device Lot Number: 3000043013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Device Age: YR
• Date Manufacturer Received: 03/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 65