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

Model Number 0684-00-0296-02

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

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 the customer had two intra-aortic balloons (iab) that had malfunctioned.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 report for "insufficient failure information" is operating within its risk profile.A labeling review is not able to be completed since a specific failure was not reported.There were no ncmrs identified from the ship history which could cause or contribute to the reported event.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 the customer had two intra-aortic balloons (iab) that had malfunctioned.There was no patient harm or adverse event reported.

• Brand Name: MEGA 8FR. 50CC 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: 11371958
• MDR Text Key: 233264199
• Report Number: 2248146-2021-00127
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108018
• UDI-Public: 10607567108018
• Combination Product (y/n): N
• PMA/PMN Number: K091449
• 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: 05/21/2021

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 Expiration Date: 02/05/2023
• Device Model Number: 0684-00-0296-02
• Device Catalogue Number: 0684-00-0497
• Device Lot Number: 3000114163
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 05/21/2021
• Supplement Dates FDA Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1