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

Catalog Number 0684-00-0434

Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976)

Patient Problems Death (1802); Ischemia (1942)

Event Date 06/04/2019

Event Type  Death  

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).Device not returned.

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the doctor called into getinge with questions regarding catheter kink and restriction alarms on the cardiosave intra-aortic balloon pump (iabp).The doctor stated that they had inserted an intra-aortic balloon (iab) the previous week and in transfer of the patient from the catheterization lab to clinical care, the iab had pulled down into the aortic iliac area, near the femoral artery.It was reported that no alarm on the iabp was noted.It was also reported that the patient lost pulses and the leg was discolored.The patient was already unstable and critically ill with multiple issues.The patient reportedly expired the following morning.Clinical nurse specialist (cns) reported that the iab being pulled down into the incorrect position was a result of human error.The cns stated that the iab was not saved due to the balloon working correctly and did not feel that it was a balloon issue.The facility does not attribute the death to the device.

• Brand Name: SENSATION 7FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 8752432
• MDR Text Key: 149767127
• Report Number: 2248146-2019-00568
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0434
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: No
• 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): Death
• Patient Age: 51 YR
• Patient Weight: 57