MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0575

Device Problems Suction Problem (2170); Inappropriate Waveform (2536)

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

Event Date 12/01/2023

Event Type  malfunction  

Event Description

It was reported that immediately after inserting the intra-aortic balloon (iab), the md was unable to aspirate.They repositioned the iab and reattempted to aspirate but were still unable to.After 30 minutes, the iab was successfully replaced with a new one to continue therapy.There was no patient harm or adverse event reported.

Manufacturer Narrative

Initial reporter occupation: inventory control coordinator, cath lab.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).

Manufacturer Narrative

Device evaluation: the product was returned with the membrane completely unfolded and blood on the exterior of the catheter.The extender tubing was also returned.A kink was found on the catheter tubing and inner lumen approximately 66.8cm from the iab tip.The technician attempted to flush/aspirate the inner lumen and was unable to do so.The technician then attempted to insert a 0.018¿ laboratory guide wire through the inner lumen and resistance was only felt at the kinked location.A sensor output test was performed and the sensor was found to be within specification.A kink in the inner lumen can cause difficulty to aspirate the inner lumen.We are unable to determine when the kink may have occurred.The evaluation confirmed the reported difficult to aspirate.The reported difficult/unable to monitor waveform cannot be confirmed by the evaluation.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.

Event Description

It was reported that immediately after inserting the intra-aortic balloon (iab), the md was unable to aspirate.They repositioned the iab and reattempted to aspirate but were still unable to.It was noted that a no waveform detected alarm was generated.After 30 minutes, the iab was successfully replaced with a new one to continue therapy.There was no patient harm or adverse event reported.

• Brand Name: SENSATION PLUS 8FR. 50CC 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: 18378250
• MDR Text Key: 331381006
• Report Number: 2248146-2023-00728
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: 10607567108605
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 300030048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 82 KG