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

Catalog Number 0684-00-0605

Device Problems Unraveled Material (1664); Difficult to Open or Remove Packaging Material (2922)

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

Event Date 12/19/2021

Event Type  malfunction  

Manufacturer Narrative

Complete event site name: (b)(6).Hospital 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 during insertion of the intra-aortic balloon(iab), the balloon did not come off easily from the retainer.When it did come out, the balloon unfurled and was unable to be used.Negative pressure was applied with the attached syringe with a one-way valve, and it was handled according to the method described in the package instructions.There was no reported injury or adverse event to the patient.

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 jan-2020 through dec-2021 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint # (b)(4).

• Brand Name: TRANS-RAY PLUS 7.5 FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 13228326
• MDR Text Key: 285041396
• Report Number: 2248146-2022-00031
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2022
• Device Catalogue Number: 0684-00-0605
• Device Lot Number: 3000091324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/08/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 56 KG