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

Catalog Number 0684-00-0575

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2024

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.Reference complaint #(b)(4).H3 other text : device not returned.

Event Description

It was reported that during intra-aortic balloon (iab) therapy, blood was noticed in the helium tubing and had leaked back to the cardiosave intra-aortic balloon pump (iabp).The helium tubing as clamped and disconnected.The insertion was reported to be axillary, which is not a method described in the instructions for use (ifu).The iab was replaced and therapy was provided.There was no patient harm or adverse event reported.This report is for the iab.A separate report was submitted for the intra-aortic balloon pump (iabp) under mfg report number 2249723-2024-01217.

Manufacturer Narrative

The iab was returned cut in two parts with blood on the interior and exterior of the device.The sheath hub was returned over a portion of the membrane.The sheath tubing was cut fromt the sheath and not returned.The sensor cable and extracorporeal tubing was cut from the iab and not returned.Two kinks were observed on the inner lumen approximately 5.1cm and 6.1cm from iab tip.An underwater leak test of the portion of the balloon and catheter tubing was performed and no leaks were detected.The 2nd part of the membrane was unable to be leak tested due to the returned condition.However a visual examination of the membrane discovered a penetration on the membrane approximately 6.9cm from the iab tip measuring 0.064cm in length.The reported problem was most likely triggered by a leak which was found on the membrane.The penetration found on the membrane appears to have been caused by a sharp object.However, we are unable to conclusively determine the the primary cause of the event due to the returned condition of the device.The insertion was reported to be axillary, which is not the method described in the device instructions for use.This may have contributed to the iab failure.The evaluation confirmed the reported problem a lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint #(b)(4).

• Brand Name: SENSATION PLUS 8FR. 50CC 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: 19015216
• MDR Text Key: 339058007
• Report Number: 2248146-2024-00188
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: 10607567108605
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112327
• 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: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000309366
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARDIOSAVE / CH263204I7
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 64 KG