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

Model Number N/A

Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Material Deformation (2976)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/05/2019

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.A getinge representative later apologized to the customer in regards to his experience and explained to the surgeon that the balloon would not normally easily pass through the sheath.The getinge representative informed the customer that getinge advises that the iab catheter be inserted as soon as the patient's condition starts to deteriorate, to avoid complications and that if the catheter is inserted sheathless, the patient is less likely to develop limb ischemia.The getinge representative advised the customer that getinge has not changed their guidewires or dilators, and they have been the same for over 10 years; and possibly have not been changed since they were first introduced.The getinge representative responded with regards to removal through the sheath and advised the customer that getinge¿s catheters have never been designed to be able to be removed through the sheaths; in addition, when the catheter is inflated the diameter is considerably larger than when it was in the packaging.The iab kits involved in the event were requested to be returned to getinge for further investigation, if available.No investigation of the involved iabp is required, as there was no reported malfunction of the unit.

Event Description

It was reported that the patient required an intra-aortic balloon pump (iabp) for support, post-operatively.The surgeon was unable to insert the intra-aortic balloon (iab) in the theatre due to poor peripheral access; therefore, the patient went to intensive therapy unit (itu) without support.Later on that night, the patient started struggling and the on-call anaesthetist/intensivist determined that the patient needed circulatory support; and decided to insert an iab; particularly as by this point the arterial traces were dampened, and he also wanted a more accurate pressure reading.The intensivist attempted to insert a 50cc fiber-optic catheter.It was reported that the insertion was successful, but was very difficult to do.It was necessary to use a sheath to maintain patency of the vessel as the patient had a very large abdomen.The surgeon went through two introducer kits because the guidewires and dilators kept kinking.Overall, this worked well, except that the patient¿s leg in which the iab was inserted began to blanche.Eventually, the decision was made to go back to theatre.The patient was subsequently put on extracorporeal membrane oxygenation (ecmo) and the iab was removed.The surgeon reported that it was difficult for him to remove the balloon, and he complained that the catheter should have been able to pass through the sheath.The surgeon requested that the balloon and sheath be kept for inspection by getinge.He also requested that getinge be informed of his dissatisfaction at his perceived reduction in quality of the iab and its insertion kit.The surgeon also reported that the insertion was very traumatic for the patient and the patient had to have vascular repair.There was no reported malfunction of the iabp involved in this event.This report is related iab complaints (b)(4).

• Brand Name: CARDIOSAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 8380310
• MDR Text Key: 137510599
• Report Number: 2249723-2019-00321
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2019

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: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Device Age: YR
• Initial Date Manufacturer Received: 02/06/2019
• Initial Date FDA Received: 02/28/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 105