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

Catalog Number 0684-00-0514

Device Problem Restricted Flow rate (1248)

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

Event Date 06/18/2021

Event Type  malfunction  

Manufacturer Narrative

Event site postal code: (b)(6).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 immediately after insertion of the intra-aortic balloon (iab), the console frequently generated check iab catheter and catheter restriction alarms.The iab was checked and no issues were found.The console was swapped out with a different one, but the problem continued.The extension tube was removed and the expansion of the iab was confirmed by fluoroscopy while pushing it by hand with a syringe.The iab was removed and replaced with a new one, but the issue was not resolved and the cause could not be determined.When the augmentation pressure was lowered, the drive became stable and the alarm could be avoided so therapy was continued.Approximately 16 hours later, the second iab was also removed.It was noted that another manufacturer's sheath was used.There was no patient harm or adverse event reported.This report is for the first iab used in this event.A separate report will be submitted for the second iab used.

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 (b)(6) to (b)(6) was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).H3 other text: device not returned.

Event Description

N/a.

• Brand Name: TRANS-RAY 7FR. 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: 12134951
• MDR Text Key: 260677810
• Report Number: 2248146-2021-00442
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

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: 06/19/2023
• Device Catalogue Number: 0684-00-0514
• Device Lot Number: 3000123658
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2021
• Initial Date FDA Received: 07/08/2021
• Supplement Dates Manufacturer Received: 08/05/2021
• Supplement Dates FDA Received: 08/05/2021
• Patient Sequence Number: 1
• Treatment: CARDIOSAVE/TERUMO CORPORATION 8FR SHEATH.
• Patient Age: 60 YR
• Patient Weight: 75