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

Model Number 0684-00-0295-01

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/03/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device will not be 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 right after insertion of the intra-aortic balloon (iab) the lumen was found to be clotted.It was noted that the patient was being transferred to another facility while they are still being supported by the iab.There was no patient harm or adverse event reported.

Event Description

It was reported that right after insertion of the intra-aortic balloon (iab) the lumen was found to be clotted.It was noted that the patient was being transferred to another facility while they are still being supported by the iab.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.Reference complaint # (b)(4).

• Brand Name: MEGA 7.5FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• MDR Report Key: 11870114
• MDR Text Key: 253537367
• Report Number: 2248146-2021-00326
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107974
• UDI-Public: 10607567107974
• Combination Product (y/n): N
• PMA/PMN Number: K120868
• 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: 05/28/2021

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: 03/13/2023
• Device Model Number: 0684-00-0295-01
• Device Catalogue Number: 0684-00-0293
• Device Lot Number: 3000116949
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/03/2021
• Initial Date FDA Received: 05/24/2021
• Supplement Dates Manufacturer Received: 05/28/2021
• Supplement Dates FDA Received: 05/28/2021
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 58