MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD UNKNOWN INTRA-AORTIC BALLOON; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number UNKNOWN

Device Problems Inability to Auto-Fill (1044); Off-Label Use (1494); Gas/Air Leak (2946)

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

Event Date 09/15/2021

Event Type  malfunction  

Manufacturer Narrative

Complete event site name: (b)(6) hospital.Complete initial reporter name: (b)(6).Occupation: administrator/ supervisor.The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint record id # (b)(4).

Event Description

It was reported that after weeks of intra-aortic balloon (iab) therapy on a pre-transplant patient, the console generated gas loss and autofill failure alarms.The insertion was reported to be axillary, which is not the method described in the device instructions for use.The customer swapped out the console for a different one, but the same issue occurred.The patient was taken for iab repositioning/ replacement.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.Analysis of production (3331/213) - 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 (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period sep-2019 through aug-2021 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).

Event Description

N/a.

• Brand Name: UNKNOWN INTRA-AORTIC BALLOON
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• MDR Report Key: 12576774
• MDR Text Key: 274746433
• Report Number: 2248146-2021-00650
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• 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: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2021
• Patient Sequence Number: 1
• Treatment: CARDIOSAVE; CARDIOSAVE
• Patient Age: 47 YR
• Patient Weight: 88