MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0433

Device Problems Failure to Advance (2524); Material Twisted/Bent (2981)

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

Event Date 10/03/2018

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 prior to intra-aortic balloon (iab) therapy, as the guide wire was inserted, it presented a kink which impeded the advancement of the iab.The indication for use was ventricular failure.A new iab was used to continue therapy.There was no reported injury to the patient.

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 prior to intra-aortic balloon (iab) therapy as the guide wire was inserted it presented a kink which impeded the advancement of the iab.The indication for use was ventricular failure.A new iab was used to continue therapy.There was no reported injury to the patient.

Manufacturer Narrative

The product was returned with the membrane loosely folded and no visible blood on the catheter.The extender tubing and insertion kit was also returned.An inner lumen kink was observed 52.8cm from iab tip.The optical fiber was found to be broken at the kinked location.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 a 0.018¿ laboratory guide wire through the inner lumen and blockage was only felt at the kinked location.The condition of the iab as received indicated a kink on the inner lumen.We are unable to determine when the kink may have occurred.Kinks on the inner lumen can cause difficulty during guide wire insertion.The evaluation confirmed the reported problem.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 prior to intra-aortic balloon (iab) therapy as the guide wire was inserted it presented a kink which impeded the advancement of the iab.The indication for use was ventricular failure.A new iab was used to continue therapy.There was no reported injury to the patient.

• Brand Name: SENSATION 7FR. 34CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 8038649
• MDR Text Key: 126715303
• Report Number: 2248146-2018-00630
• Device Sequence Number: 0
• Product Code: DSP
• 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,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2021
• Device Catalogue Number: 0684-00-0433
• Device Lot Number: 3000073084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Device Age: YR
• Initial Date Manufacturer Received: 10/11/2018
• Initial Date FDA Received: 11/05/2018
• Supplement Dates Manufacturer Received: 11/19/2018; 12/12/2018
• Supplement Dates FDA Received: 12/11/2018; 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR