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

Model Number N/A

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

Patient Problem Cardiac Arrest (1762)

Event Date 11/09/2019

Event Type  Injury  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit cannot be reviewed per the sop since the serial number for the unit was not provided.There was no reported malfunction of the iabp and a getinge company representative has confirmed that no anomalies or malfunctions were noted on the involved pump used with the reported iab catheter and no repair is required.In addition, neither the iabp model or serial number was provided by the facility.No further investigation is required.Not returned to manufacturer.

Event Description

It was reported that during unspecified intra aortic balloon pump (iabp) therapy, the intra aortic balloon catheter (iabc) in the kit was inserted and the iabc was inserted into the sheath according to the determined procedure and there was no resistance.Since the wrapping was completely unwound/unfurled and could not be used, the patient's condition suddenly changed while another iab kit was opened and replaced with a competitor's 8fr sheath, and eventually the iabc was not placed.The competitor¿s sheath was delivered to the appropriate position, then a second iabc was used.While the second iabc was being primed outside of the patient, the patient went into cardiac arrest.Cardiopulmonary resuscitation was performed.According to the physician, as the patient was reported to have been in unstable condition, neither the iabc or the procedure were related to the cardiac arrest.The second iab catheter was not clinically used in the patient.The postoperative condition of the patient was not provided by the facility.According to the information from the facility, there is no causal relationship between the patient adverse event and the iabp therapy.Refer to mfg report number 2248146-2019-00900 for information on the involved iab.

Manufacturer Narrative

Please note that information regarding the model of the involved iabp has been obtained to be cardiosave, but the serial number has not been provided to us.In addition, we have again been advised that no anomalies nor malfunctions were noted on the concomitant iabp.

Event Description

It was reported that during cardiosave intra aortic balloon pump (iabp) therapy, the intra aortic balloon catheter (iabc) in the kit was inserted and the iabc was inserted into the sheath according to the determined procedure and there was no resistance.Since the wrapping was completely unwound/unfurled and could not be used, the patient's condition suddenly changed while another iab kit was opened and replaced with a competitor's 8fr sheath, and eventually the iabc was not placed.The competitor¿s sheath was delivered to the appropriate position, then a second iabc was used.While the second iabc was being primed outside of the patient, the patient went into cardiac arrest.Cardiopulmonary resuscitation was performed.According to the physician, as the patient was reported to have been in unstable condition, neither the iabc or the procedure were related to the cardiac arrest.The second iab catheter was not clinically used in the patient.The postoperative condition of the patient was not provided by the facility.According to the information from the facility, there is no causal relationship between the patient adverse event and the iabp therapy.Refer to mfg report number 2248146-2019-00900 for information on the involved iab.

• Brand Name: CARDIOSAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 9396033
• MDR Text Key: 170038685
• Report Number: 2249723-2019-01928
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRANSRAY PLUS 35CCCOMPETITOR'S BALLOON; TRANSRAY PLUS 35CCCOMPETITOR'S BALLOON
• Patient Outcome(s): Life Threatening; Required Intervention