MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0469-01

Device Problem Difficult to Remove (1528)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/31/2023

Event Type  malfunction  

Manufacturer Narrative

Occupation: cardiac cath lab manager.Additional contact person information: (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.Complaint record id#: (b)(4).H3 other text : device not returned.

Event Description

It was reported that the customer experienced difficulty removing the intra-aortic balloon (iab) after a successful pci angioplasty and placing two stents.Dilatation of the entry point was required in order to get the distal tip of the iab through the femoral artery.This resulted in injury to the patient's arteriotomy site and significant bleeding.The patient was given blood products.Sheering of the device was noted.The physician was concerned that there was "metal" at the distal tip of the iab.Upon inspection, the getinge representative noticed the iab had a sheath still attached between the base of the iab membrane and the white y-fitting of the iab.The sheath was blue in color and had a side port attached to it.This sheath was not the provided getinge sheath.At the distal tip of the iab, the membrane appeared to be cut open, which was cut by the customer after removal in order to inspect it.Medwatch#: (b)(4).Iabp was placed at an outside facility.Patient was transferred to this hospital for further interventional treatment.Pci angioplasty conducted.Two stents placed successfully.Attempted to remove the balloon pump but the distal tip would not come through the femoral artery.Able to remove after dilatation of the entry point which resulted in significant bleeding.Sheering of the device noted.

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint # (b)(4).

Event Description

N/a.

• Brand Name: SENSATION 7FR. 34CC 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: 16806318
• MDR Text Key: 313911375
• Report Number: 2248146-2023-00279
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567106755
• UDI-Public: 10607567106755
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2023
• Device Model Number: 0684-00-0469-01
• Device Catalogue Number: 0684-00-0433
• Device Lot Number: 3000136901
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/11/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NON-GETINGE SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female