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

Catalog Number 0684-00-0475

Device Problems Material Deformation (2976); Pressure Problem (3012)

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

Event Date 01/11/2024

Event Type  malfunction  

Manufacturer Narrative

Initial reporter: (b)(6) additional initial reporters additional email address additional phone number.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.Reference complaint (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, there was a temporary loss of arterial pressure waveform.Eventually, the signal was able to return and therapy continued.There was no patient harm or adverse event reported.

Manufacturer Narrative

Updated fields: date of event describe event or problem other relevant history serial # medical device ¿ problem code (2) 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.Reference complaint #(b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, there was an immediate temporary loss of arterial pressure waveform.The balloon was also reported to be pinched.Eventually, the signal was able to return and therapy continued.There was no patient harm or adverse event reported.

Manufacturer Narrative

The iab was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter and between the catheter and the sheath.The extracorporeal tubing was cut from the iab and not returned.No kinks were observed on the iab catheter.The technician attempted to insert a 0.025¿ laboratory guide wire through the inner lumen of the returned iab and found that the inner lumen occluded.The technician was unable to clear the occlusion, however evidence of dried blood was observed at the tip of the guide wire.An underwater leak test of the balloon, catheter and y-fitting was performed and a leak was observed on the catheter tubing approximately 54.1cm from iab tip.The condition of the iab as received indicated a penetration on the catheter tubing and the inner lumen occluded with blood.An occlusion in the inner lumen can cause difficulty monitoring the pressure.The penetration found in the catheter tubing appears to have been caused by a sharp object.We are unable to determine how this may have occurred.The evaluation confirmed the reported difficulty to monitor the pressure.The evaluation was unable to confirm a kink.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint # (b)(4).

Event Description

N/a.

• Brand Name: LINEAR 7.5FR. 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: 18851656
• MDR Text Key: 337071766
• Report Number: 2248146-2024-00142
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567106564
• UDI-Public: 10607567106564
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000330593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Sex: Male
• Patient Weight: 83 KG