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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).
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Manufacturer (Section D)
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer (Section G)
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key8380310
MDR Text Key137510599
Report Number2249723-2019-00321
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 02/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received02/06/2019
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 Treatment Data
Date Received: 02/28/2019 Patient Sequence Number: 1