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

Model Number N/A

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

Patient Problems Arrhythmia (1721); Cardiac Arrest (1762)

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

No repair performed on the intra-aortic balloon pump (iabp).The full name of the initial reporter is (b)(6).Not returned to manufacturer.

Event Description

It was reported that the iabp (intra-aortic balloon pump) alarmed ¿check catheter¿.No visible blood noted.Patient arrested as a result of multiple dysrhythmias.During cpr, blood was noted to be coming into the iabp catheter.It was then clamped.Postcode (patient deceased) iabp pulled, the iab (intra-aortic balloon) noted to have ¿ruptured¿.The iab catheter device rupture is reported in a separate mdr.Medwatch # mw4099641 received 09-march-2021.Describe event, problem or product use error nstemi complicated by vt arrest.Coronary angiogram demonstrated severe multivessel disease.Iabp placed.On (b)(6) 2021, patient experienced labile blood pressure and at 7 pm required increasing vasopressors.Onset of afib increasing ectopy (pacs, pvcs).Iabp began to alarm with messages, check catheter position and auto r wave deflation".Cpr was initiated.At end of cpr, small amount of blood noted in helium line.Patient in pulseless vt despite on-going efforts and family consulted.Decision made to transition to comfort measures only and resuscitation discontinued.Upon removal of catheter/balloon, small hole in balloon noted.

Manufacturer Narrative

Updated fields: b2, b4, b6, g3, g6, g7, h2, h6(investigation type), h10, h11 corrected fields: g1(contact person).The customer has not requested for getinge to evaluate the iabp involved in this event.The customer is not making the allegation that the iabp attributed to the patient¿s death.They only asked for the balloon to be examined regarding the leak allowing blood to enter the balloon.The customer contacted getinge several days after the balloon event but was unable to identify pump.This complaint is being closed.If additional information is received, we will reopen and update the complaint.Balloon complaint report number: 2248146-2021-00192.

Event Description

N/a.

• Brand Name: UNKONWN
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 11575259
• MDR Text Key: 242439571
• Report Number: 2249723-2021-00639
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/26/2021
• Supplement Dates Manufacturer Received: 06/09/2023
• Supplement Dates FDA Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER SENSATION PLUS 40CC; BALLOON CATHETER SENSATION PLUS 40CC
• Patient Outcome(s): Death
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 81 KG