MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS IAB CATHETER; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Low Blood Pressure/ Hypotension (1914); Swelling (2091); Cardiac Tamponade (2226)

Event Date 07/06/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) catheter was removed with femostop applied.The customer had some concern after the removal due to a swelling rif however it was thought to be due to the position of the femostop.The patient's blood pressure dropped to 59/39 and fluids were given.A ct scan was performed immediately.Once the bleeding point was identified the patient was taken to the cath lab for a cardiac tamponade.The vascular surgeons stated that there has been difficulty when removing this type of iab catheters in comparison to the non-fiber optic model.However the facility does not attribute the injury to the device.The event date is unknown.

Manufacturer Narrative

Event date added to section date of event.(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) catheter was removed with femostop applied.The customer had some concern after the removal due to a swelling rif however it was thought to be due to the position of the femostop.The patient's blood pressure dropped to 59/39 and fluids were given.A ct scan was performed immediately.Once the bleeding point was identified the patient was taken to the cath lab for a cardiac tamponade.The vascular surgeons stated that there has been difficulty when removing this type of iab catheters in comparison to the non-fiber optic model.However the facility does not attribute the injury to the device.

• Brand Name: SENSATION PLUS IAB CATHETER
• 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: 6817142
• MDR Text Key: 83513041
• Report Number: 2248146-2017-00323
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2017
• 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 Outcome(s): Life Threatening; Required Intervention