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

Model Number 0684-00-0480-01

Device Problems Difficult to Remove (1528); Pressure Problem (3012)

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

Event Date 07/27/2021

Event Type  malfunction  

Manufacturer Narrative

Occupation: cardiac surgeon.(b)(6).The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Complaint record id # (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the guidewire was difficult to remove.Once the iab was connected to the console, the arterial curve was not displayed properly.A new iab was inserted without further issue.There was no patient harm or adverse event reported,.

Manufacturer Narrative

The iab was returned with the membrane completely unfolded.No blood was visible on the catheter.The guide wire was returned unraveled outside of the iab.The returned guide wire was unable to be used for testing due to its returned condition.The technician attempted to insert a laboratory 0.025¿ guide wire through the inner lumen and was able to successfully insert the guide wire.No obstructions were felt.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The reported events cannot be confirmed by the evaluation.A non-conforming material report review was completed for the reported product.No nonconformances were found that are considered to be related to the event.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 aug-2019 through jul-2021 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #505346.

• Brand Name: LINEAR 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
• MDR Report Key: 12370262
• MDR Text Key: 268227614
• Report Number: 2248146-2021-00551
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567106564
• UDI-Public: 10607567106564
• Combination Product (y/n): N
• PMA/PMN Number: K041281
• 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: 10/13/2021

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: 03/28/2022
• Device Model Number: 0684-00-0480-01
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000093376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Initial Date Manufacturer Received: 08/05/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 10/13/2021
• Supplement Dates FDA Received: 10/13/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 75 YR
• Patient Weight: 73