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

Catalog Number 0684-00-0575

Device Problem Leak/Splash (1354)

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

Event Date 04/04/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Reference complaint #1017005 h3 other text : device not returned.

Event Description

It was reported that while inserting the intra-aortic balloon (iab), blood had leaked before the iab reached its proper placement.This issue occurred again on three additional iabs.The customer ultimately used another manufacturer's iab to provide therapy.There was no patient harm or adverse event reported.This report is for the first iab used in this event.Separate reports will be submitted for the additional three iabs involved in this event.

Event Description

It was reported that while inserting the intra-aortic balloon (iab), blood had leaked before the iab reached its proper placement.This issue occurred again on three additional iabs.The customer ultimately used another manufacturer's iab to provide therapy.There was no patient harm or adverse event reported.This report is for the first iab used in this event.A separate report was submitted for the second iab under mfg report number 2248146-2024-00255.Another separate report was submitted for the third iab under mfg report number 2248146-2024-00256.Also, another separate report for the fourth iab was submitted under mfg report number 2248146-2024-00257.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the exterior of the catheter with the one-way valve attached.No blood was observed inside the iab catheter.A video was provided and reviewed.A kink was observed on the catheter tubing near the y-fitting approximately 76.2cm from iab tip.The one-way valve was vacuum tested and it held vacuum.An underwater leak test of the balloon, catheter, y-fitting, and extracorporeal tubing was performed and no leaks were detected.The reported event cannot be confirmed by the evaluation.Arterial blood under pressure may run the length of the folds in the balloon membrane and drip or be expelled under arterial pressure from the balloon/catheter junction.This "channeling" is not a leak and will diminish as the iab catheter is inserted.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).

Manufacturer Narrative

Correction to emdr follow up #1 to field "type of investigation (6)" to include analysis of information provided by user/third party|4112.Reference complaint #(b)(4).

Event Description

N/a.

• 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: 19173079
• MDR Text Key: 341679436
• Report Number: 2248146-2024-00254
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2024

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 Catalogue Number: 0684-00-0575
• Device Lot Number: 3000355194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: 05/17/2024; 05/17/2024
• Supplement Dates FDA Received: 05/17/2024; 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.