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

Catalog Number 0684-00-0605

Device Problem Pressure Problem (3012)

Patient Problem Cardiac Tamponade (2226)

Event Date 07/28/2021

Event Type  Injury  

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).

Event Description

It was reported that the intra-aortic balloon (iab) was inserted and the blood pressure signal was inputted via fiber optic sensor.The central lumen was primed with heparinized saline.The patient presented with cardiac tamponade and thoracotomy was performed.At that time, the blood pressure signal input via the fiber optic sensor was dull.The customer then tried to obtain the blood pressure signal from the central lumen with a transducer, but the central lumen was clogged and the customer was unable to obtain the pressure signal.The iab was then replaced with a new one, which functioned without issue.The removed iab was later inspected and a defect was seen on the tip of the device as well as what seemed to be a piece of tissue was attached.

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.Analysis of production (b)(4) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis(b)(4) - the review of the historical data was performed.Trend analysis (b)(4) - the overall complaint trend data for the period (b)(6) through (b)(6) was reviewed.Communication/interviews: (b)(4) communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, d10, g4, h3, h6, h10.The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Reference complaint (b)(4).

Manufacturer Narrative

Updated sections- serial #, lot #.The product was returned with the membrane completely folded with blood on the exterior of the catheter and between the catheter and the returned non-maquet sheath, which was covering the proximal taper end of the membrane.The sheath¿s sideport was cut.The cut piece as not returned for evaluation.The extender tubing was also returned.A catheter tubing kink was observed at approximately 75.7cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing and extender tubing was performed and no leaks were detected.A 0.025¿ laboratory guidewire was inserted through the inner lumen and was found to be occluded with dry blood.Unable to clear the occlusion.A sensor output test was performed and a pressure reading could not be obtained.An optical fault locator was used to detect any breaks along the optical fiber¿s length no breaks were observed.The evaluation confirmed the reported difficulty monitoring the pressure waveform caused by the occluded inner lumen.Additionally, this failure could have also been caused by the sensor failure which has been escalated to respective supplier to determine a root cause.However, the evaluation did not find any indication of an iab tip defect.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.Reference complaint (b)(4).

• Brand Name: TRANS-RAY PLUS 7.5 FR. 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: 12338630
• MDR Text Key: 267137034
• Report Number: 2248146-2021-00536
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2023
• Device Catalogue Number: 0684-00-0605
• Device Lot Number: 3000117326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Outcome(s): Required Intervention