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

Model Number N/A

Device Problem Positioning Problem (3009)

Patient Problems Ischemia (1942); Discomfort (2330)

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.If additional information is provided, a supplemental report will be submitted.

Event Description

This complaint was reported by getinge's corporate medical affairs manager via an article in the 22nd annual scientific meeting, hfsa s119 / s120 journal of cardiac failure vol.24 no.8s august 2018.As follows: a (b)(6) male with end stage heart failure on a bridge to transplant experienced abdominal discomfort during intra-aortic balloon pump (iabp) therapy.The intra-aortic balloon catheter (iabc) was by via axillary insertion and an abdominal ct scan found mesenteric ischemia, iabp tip in sma (superior mesenteric artery).The iabc was repositioned and the abdominal discomfort was resolved.The article did not provide any information on whether the balloon pump in use at the time was a maquet/getinge intra-aortic balloon pump or allege a malfunction thereof of the involved iabp; however, the event site is a getinge account.A getinge service territory manager (stm) contacted the customer and was advised that no patient information or further event details was available.A separate report was submitted on the iabc suspected to be involved in this event under medwatch #2248146-2018-00652.

• Brand Name: UNKNOWN
• 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: 8067443
• MDR Text Key: 127061051
• Report Number: 2249723-2018-01957
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• 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
• Device Age: YR
• Date Manufacturer Received: 10/19/2018
• 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): Required Intervention
• Patient Age: 58 YR