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

Model Number 0684-00-0568-01

Device Problems Inappropriate Waveform (2536); Pressure Problem (3012)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)

Event Date 03/02/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Complaint record id # (b)(4).

Event Description

Medwatch received on 16-march-2021.The patient was about to have emergent coronary angiography, became hypotensive, developed vf and received multiple rounds of defibrillation, cardiopulmonary resuscitation (cpr) and inotropes.The team then placed an iabp.The patient arrested again and received @6 minutes cardiopulmonary resuscitation (cpr) with aggressive resuscitation efforts.A 40cm iabp was placed in excellent position and set at 1:1.There was initially excellent augmentation however, over several minutes time the map persistently dropped requiring confirmation of central pressures with the use of an omniflush catheter placed in the proximal aorta.Again, the patient became hypotensive to the 40s systolic despite aggressive inotropes.The balloon pump waveform had an odd appearance that suggested the patient had no underlying native pressure.This was confirmed by putting the balloon pump on hold which demonstrated no native pressure.Aggressive cardiopulmonary resuscitation (cpr) and resuscitative efforts were reinstituted for an additional 5 minutes which did not result in restoration of a perfusing pressure or rhythm.Therefore all further efforts at resuscitation.

Event Description

Medwatch received on 16-march-2021.The patient was about to have emergent coronary angiography, became hypotensive, developed vf and received multiple rounds of defibrillation, cardiopulmonary resuscitation (cpr) and inotropes.The team then placed an iabp.The patient arrested again and received @6 minutes cardiopulmonary resuscitation (cpr) with aggressive resuscitation efforts.A 40cm iabp was placed in excellent position and set at 1:1.There was initially excellent augmentation however, over several minutes time the map persistently dropped requiring confirmation of central pressures with the use of an omniflush catheter placed in the proximal aorta.Again, the patient became hypotensive to the 40s systolic despite aggressive inotropes.The balloon pump waveform had an odd appearance that suggested the patient had no underlying native pressure.This was confirmed by putting the balloon pump on hold which demonstrated no native pressure.Aggressive cardiopulmonary resuscitation (cpr) and resuscitative efforts were reinstituted for an additional 5 minutes which did not result in restoration of a perfusing pressure or rhythm.Therefore all further efforts at resuscitation.

Manufacturer Narrative

Additional information: added serial #.Device evaluation: the product was returned with the membrane completely unfolded and blood on the exterior of the catheter.A kink was found on the inner lumen and catheter tubing approximately 68.3cm from the iab tip.The optical fiber was found to be broken at the kinked location.The inner lumen was found occluded with dried blood.The occlusion was unable to be cleared.The optical fiber was found to be broken, confirming the reported problem.We are unable to determine when this may have occurred.A non-conforming material report review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.The review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.The overall 24 month product complaint trend data for the period april2019 - march 2021 was reviewed.There were no triggers identified for the review period.Communication/interviews were performed to obtain all possible information.Reference complaint # (b)(4).

• Brand Name: SENSATION PLUS 7.5FR. 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• MDR Report Key: 11618713
• MDR Text Key: 244201099
• Report Number: 2248146-2021-00218
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108063
• UDI-Public: 10607567108063
• Combination Product (y/n): N
• PMA/PMN Number: K122628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2023
• Device Model Number: 0684-00-0568-01
• Device Catalogue Number: 0684-00-0567
• Device Lot Number: 3000116944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Initial Date Manufacturer Received: 03/09/2021
• Initial Date FDA Received: 04/06/2021
• Supplement Dates Manufacturer Received: 06/22/2021
• Supplement Dates FDA Received: 06/22/2021
• Patient Sequence Number: 1
• Treatment: OMNIFLUSH CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 82