MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0567

Device Problem Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/09/2023

Event Type  Death  

Manufacturer Narrative

Additional reporter(s): (b)(6).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.Complaint record id # (b)(4).

Event Description

It was reported that during an in-service, the cath lab manager asked the getinge representative to follow up on an event at a neighboring hospital.It was explained that patient had been transferred to another hospital during intra-aortic balloon (iab) therapy and ultimately passed away.It was noted that the iab was dislodged due to the two statlocks detaching from the patient.The cath lab manager explained that the dressing was applied per hospital policy and provided photo documentation of the dressing before patient transport.A nurse rode with the patient during transport and charted that the dressing was secure and intact upon arrival.The getinge representative explained that getinge provides statlocks and securement is per provider preference.Upon follow up with the doctors at the second hospital, it was discovered that the iab was ripped out when they removed the tegaderm dressing because the catheter was not sutured.The or (operating room) tech explained that it is policy to remove all dressings and sutures to prep the leg in the or.It was noted that the iab was dislodged 20cm out of the sheath when removing the dressing for prep.After catheter displacement, the patient's therapy was interrupted for 4 minutes and they began to deteriorate.A new iab was inserted through the same sheath within 4 minutes but the patient ultimately expired.

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint#: (b)(4).

Event Description

N/a.

• Brand Name: SENSATION PLUS 7.5FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 18033474
• MDR Text Key: 326903700
• Report Number: 2248146-2023-00643
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108063
• UDI-Public: 10607567108063
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0567
• Device Lot Number: 3000319343
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TEGADERM.
• Patient Outcome(s): Death
• Patient Age: 69 YR
• Patient Sex: Female