MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0470-01

Device Problems Filling Problem (1233); Restricted Flow rate (1248); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2020

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.Complaint record id # (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the console generated a catheter restriction alarm and auto-fill failures occurred.The customer repositioned the iab but the issue continued.A long period of auto-fill failure occurred followed by over 30 minutes with the console in stand-by mode as the customer inflated the iab manually.The iab was then removed.The insertion of the iab was reported to be axillary, which is not the method described in the device instructions for use.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 catheter restriction alarm and auto-fill failures occurred.The customer repositioned the iab but the issue continued.A long period of auto-fill failure occurred followed by over 30 minutes with the console in stand-by mode as the customer inflated the iab manually.The iab was then removed.The insertion of the iab was reported to be axillary, which is not the method described in the device instructions for use.There was no patient harm or adverse event reported.

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.The failure modes are addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failures.There were no ncmrs identified which could cause or contribute to the reported failures.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).

• Brand Name: SENSATION 7FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 11100787
• MDR Text Key: 227274894
• Report Number: 2248146-2020-00702
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567106779
• UDI-Public: 10607567106779
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• 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: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0684-00-0470-01
• Device Catalogue Number: 0684-00-0434
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 04/23/2021
• Supplement Dates FDA Received: 04/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARDIOSAVE-HYBRID SN# (B)(4)
• Patient Age: 53 YR
• Patient Weight: 61