MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0575

Device Problems Gas Output Problem (1266); Difficult to Remove (1528); Physical Resistance (2578); Device Displays Incorrect Message (2591)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 07/22/2017

Event Type  Injury  

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.We continue our efforts to follow up with the customer for its return.(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) catheter , was inserted in the icu post mvr, avr, and cabgs for low cardiac output and patient deterioration.The insertion was performed by the surgeon without an image intensifier.The iab had gas loss as well as augmentation below set limit alarms.The extracorporeal tubing was assessed and blood was noted which occurred 12 hours after insertion.Resistance was felt during catheter removal attempt and the patient was taken to ot for removal.A new catheter was inserted under image intensifier in vascular ot.

Manufacturer Narrative

(b)(4).The product was returned with the membrane completely unfolded and traces of blood on the exterior of the catheter and between the catheter and the sheath.The returned sheath was over the membrane.The male luer from extracorporeal tubing and the sensor cable were cut and not returned.Dried blood was found occluding the inner lumen.The occlusion was unable to be cleared.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and 8 leaks were detected at similar locations on the membrane approximately (3) 23.6cm, (2) 24.1cm, (2) 24.4cm and 24.9cm from the rear seal measuring 0.08cm, 0.13cm and 0.18cm in length.The evaluation confirmed the reported problem which was most likely triggered by a leak which was found on the membrane.The penetration found appears to have been caused by a sharp object.It is difficult to determine how or when the penetrations occurred, however leaks found at the same location on opposite sides of the membrane is an indication that the membrane was folded.This typically occurs during the insertion process.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 the intra-aortic balloon (iab) catheter , was inserted in the icu post mvr, avr, and cabgs for low cardiac output and patient deterioration.The insertion was performed by the surgeon without an image instensifier.The iab had gas loss as well as augmentation below set limit alarms.The extracorpeal tubing was assessed and blood was noted which occurred 12 hours after insertion.Resistance was felt during catheter removal attempt and the patient was taken to ot for removal.A new catheter was inserted under image intensifier in vascular ot.

• Brand Name: SENSATION PLUS 8FR. 50CC 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: 6809877
• MDR Text Key: 83222211
• Report Number: 2248146-2017-00314
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K112327
• 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: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000040308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2017
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 98