MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

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

Patient Problem Injury (2348)

Event Date 07/18/2019

Event Type  Injury  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was unable to be reviewed as we were not able to obtain the serial number for the iabp associated with this complaint.No evaluation of the iabp has been reported as there was no alleged malfunction of the iabp unit.If additional information is made available in the future, a supplemental report will be submitted.Device evaluated by manufacturer? no reported malfunction.

Event Description

It was reported that during intra-aortic balloon pump (iabp) therapy with an unspecified pump, the operator removed the intra-aortic balloon catheter (iabc), following instructions for use (ifu) procedure.However, the unfolded balloon was stuck in the iliac artery.For removal purposes, the operator operated pta by guidewire.The balloon still could not withdraw with introducer sheath and the catheter fracture; part of the catheter was withdrawn but the balloon still remained in the patient.Finally, the patient was transferred to another hospital for open surgery (cut down surgery) and the catheter/balloon was taken out.The model name and serial number of the iabp used during this event was not provided.Furthermore, there was no reported malfunction of the iabp.The involved iabc was reported under mfg report# 2248146-2019-00650.

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.A getinge field service engineer (fse) has evaluated the iabp and upon checking the pipeline, found traces of blood in the pipeline.However, the parts required to be replaced due to blood contamination have been ordered and will be replaced and tested by the dealers engineers who will also perform system calibration and testing.The fse also advised that he completed the iabp testing and the unit can be used normally, but has been temporarily returned to the dealer's office as the ordered parts are not yet available.If additional information is provided, a supplemental report will be submitted.Updated fields: b4, b5, d1, d4 (serial# and catalog#), d10, g4, g5, g7, h2, h3, h4, h6, h10.

Event Description

It was reported that during cs300 intra-aortic balloon pump (iabp) therapy with an unspecified pump, the operator removed the intra-aortic balloon catheter (iabc), following instructions for use (ifu) procedure.However, the unfolded balloon was stuck in the iliac artery.For removal purposes, the operator operated pta by guidewire.The balloon still could not withdraw with introducer sheath and the catheter fracture; part of the catheter was withdrawn but the balloon still remained in the patient.Finally, the patient was transferred to another hospital for open surgery (cut down surgery) and the catheter/balloon was taken out.There was no reported malfunction of the iabp.The involved iabc was reported under mfg report# 2248146-2019-00650.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 8880162
• MDR Text Key: 153881970
• Report Number: 2249723-2019-01253
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• 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: 04/14/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3023-XX
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 08/09/2019
• Supplement Dates Manufacturer Received: 04/07/2020
• Supplement Dates FDA Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LINEAR 40CC BALLOON CATHETER; LINEAR 40CC BALLOON CATHETER; LINEAR 40CC BALLOON CATHETER
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 70