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

Model Number 0684-00-0576-01

Device Problem Optical Problem (3001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2020

Event Type  malfunction  

Manufacturer Narrative

Additional initial reporter name: (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 intra-aortic balloon (iab) therapy, the console generated a fiber optic sensor failure alarm. The console was swapped out with an alternative, but after approximately four hours the fiber optic sensor failed. The customer then used the transduced inner lumen to obtain the arterial pressure tracing to the pump and was able to successfully level and zero. There was no patient harm or adverse event reported.

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the console generated a fiber optic sensor failure alarm. The console was swapped out with an alternative, but after approximately four hours the fiber optic sensor failed. The customer then used the transduced inner lumen to obtain the arterial pressure tracing to the pump and was able to successfully level and zero. There was no patient harm or adverse event reported.

Manufacturer Narrative

The product was returned with the membrane completely unfolded with traces of blood on the exterior of the catheter and between the catheter and the returned maquet sheath. Two catheter tubing/inner lumen kinks were observed near the y-fitting at approximately 74. 4cm & 76. 2cm from the iab tip. Additionally, an optical fiber break was also observed at approximately 66. 3cm from the iab tip an underwater leak test of the balloon, catheter tubing, y-fitting, extracorporeal tubing and pressure tubing was performed and no leaks were detected. The optical fiber was found broken, confirming the reported problem. However, we are unable to determine how or when this may have occurred. A device and lot history record review was completed for the reported product. No nonconformances were found that are considered to be related to the event. The failure mode is addressed in the risk file and is operating within its risk profile. The ifu addresses the reported failure. There were no ncmrs identified which could cause or contribute to the reported failure. The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit. The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months). Based on the rational provided above, no escalation to the capa process is required. Reference complaint #(b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the console generated a fiber optic sensor failure alarm. The console was swapped out with an alternative, but after approximately four hours the fiber optic sensor failed. The customer then used the transduced inner lumen to obtain the arterial pressure tracing to the pump and was able to successfully level and zero. There was no patient harm or adverse event reported.

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).

• Brand Name: SENSATION PLUS 8 FR. 50CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: dorota wolpiuk ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 11101291
• Report Number: 2248146-2020-00704
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: 10607567108605
• Combination Product (y/n): N
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/19/2023
• Device Model Number: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000115025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 73 YR
• Patient Weight: 91
• Patient Treatment(s): CARDIOSAVE.