MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD UNKNOWN; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 04/29/2019

Event Type  Death  

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.Complaint record id # (b)(4).Device not returned.

Event Description

Intra-aortic balloon (iab) therapy was started in a patient with cardiopulmonary arrest.Condensation was observed inside of the catheter tubing and was manually removed.15 hours later, blood was observed in the tubing.The console generated an iab catheter restriction alarm.The iab catheter was attempted to be retracted in the sheath but it could not be pulled back into the sheath.Thus both the iab catheter and the sheath were required to remove as a unit from the patient.Prior to removal of the devices, a guidewire was attempted to be delivered through the iab catheter in order to remain the access to the proper position for placing in the descending aorta for the replacement device.However, the guidewire got stuck within the iab catheter during its delivery.Therefore, whole device including the guidewire, iab catheter and the sheath was removed from the patient.After removal of the devices, when the retrieved iab catheter was checked visually outside of the patient, the inner lumen of the balloon was found to have been damaged around its proximal portion.Another iab catheter was used instead to continue the iabp therapy.During therapy, the physician determined that the patient would not be able to recover and therapy was discontinued with the consent of the family.Approximately one to two days after discontinuation of the iabp therapy, the patient was reported to expire.The facility does not attribute the death to either device.This report is for the second iab used with no reported malfunction.

• Brand Name: UNKNOWN
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 8658152
• MDR Text Key: 146642156
• Report Number: 2248146-2019-00445
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death