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 Deflation Problem (1149); Difficult to Remove (1528)

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

Event Type  malfunction  

Manufacturer Narrative

Complete event site name: adventist health white memorial 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 removal, the intra-aortic balloon (iab) got stuck and would not come out from the introducer sheath.The customer used forceps to forcefully remove the iab which caused damage to the sheath and caused the iab to be torn.However, the iab was able to be removed from the patient and the introducer sheath shortly after that, which was bent at an angle.The getinge representative believed the iab may not have been fully deflated when attempting to remove, therefore, getting caught in the introducer sheath.There was no patient harm or adverse event reported.

Event Description

N/a.

Manufacturer Narrative

Device evaluation: the product was returned with the membrane completely unfolded and blood found on the exterior of the catheter.A kink was observed on the catheter approximately 74.9 cm from the iab tip.The optical fiber, inner lumen and balloon membrane were returned cut in half approximately 14.5cm from the iab tip.The extender tubing and pressure tubing were returned.The sheath was returned in three separate pieces and severely kinked.The inner lumen was found to be occluded.The occlusion was unable to be cleared.A laboratory insertion test was unable to be performed due to the membrane being unfurled.A laboratory deflation test and a leak test was unable to be preformed due to the returned iab condition.The reported difficult deflation cannot be confirmed by the evaluation.Additionally, we are unable to confirm the reported difficulty during insertion because of the returned condition of the catheter and we are unable to mimic the clinical setting.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).

• 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: 17912774
• MDR Text Key: 325397507
• Report Number: 2248146-2023-00615
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: 10607567108605
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 10/31/2023

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: 3000320634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2023
• Initial Date FDA Received: 10/11/2023
• Supplement Dates Manufacturer Received: 10/31/2023
• Supplement Dates FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.