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 Appropriate Term/Code Not Available (3191)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/28/2023

Event Type  Death  

Event Description

It was reported that after approximately two days of intra-aortic balloon (iab) therapy the cardiosave intra-aortic balloon pump (iabp) generated a catheter restriction alarm at 7:45am on (b)(6), 2023.The rn was immediately at bedside to assess the situation.All iabp lines and connections were checked and there were no kinks or loose connections.The md was called to the bedside.The iabp was switched out to another and with continued trouble shooting efforts the iabp was unable to be restarted.The perfusionist and intensivist were paged to bedside.The patient was reliant on support from iabp therapy and began to deteriorate without it.The patient became hypotensive and unresponsive requiring the addition of vasopressor support.Advanced cardiac life support (acls) was initiated.The patient's condition deteriorated to pulseless electrical activity (pea) arrest and family opted for comfort measures only.The patient ceased to breath (ctb) at 9:17am.This report is for the iab.A separate report for the cardiosave iabp has been submitted under mfg report number 2249723-2023-04935.

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.Complaint record id # (b)(4).Device not returned.

Event Description

N/a.

Manufacturer Narrative

Gfe response received 16jan2024 - updated field(s): date of birth.Device evaluation: the product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter and between the catheter and the sheath.The extender tubing was also returned.A kink was found on the catheter tubing and inner lumen near the y-fitting approximately 75.9cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and a leak was detected on the membrane approximately 1.3cm from the rear seal measuring 0.013cm in length.The reported problem was most likely triggered by a kink on the catheter and the leak which was found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.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).

Manufacturer Narrative

The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Reference complaint #(b)(4).

Event Description

It was reported that after approximately two days of intra-aortic balloon (iab) therapy the cardiosave intra-aortic balloon pump (iabp) generated a catheter restriction alarm at 7:45am on (b)(6) 2023.The rn was immediately at bedside to assess the situation.All iabp lines and connections were checked and there were no kinks or loose connections.The md was called to the bedside.The iabp was switched out to another, but the alarms persisted.After continued trouble shooting efforts, the iabp was unable to be restarted.The perfusionist and intensivist were paged to bedside.The patient was reliant on support from iabp therapy and began to deteriorate without it.The clinician determined that the iab was not perforated.The patient became hypotensive and unresponsive requiring the addition of vasopressor support and multiple supportive medications (dopamine, epi, levophed, vasopressin) which were effective for approximately 30 minutes.Advanced cardiac life support (acls) was initiated.The patient's condition deteriorated to pulseless electrical activity (pea) arrest and family opted for comfort measures only.The patient ceased to breath (ctb) at 9:17am.This report is for the iab.A separate report for the cardiosave iabp has been submitted under mfg report number 2249723-2023-04935.

• 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: 18226392
• MDR Text Key: 329200679
• Report Number: 2248146-2023-00691
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000322776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STENT AND TRANSVENOUS PACEMAKERCARDIOSAVE.
• Patient Outcome(s): Death
• Patient Age: 83 YR
• Patient Sex: Male