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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIO VASCULAR LLC CATHETER, INTRA-AORTIC BALLOON PUMP

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MAQUET CARDIO VASCULAR LLC CATHETER, INTRA-AORTIC BALLOON PUMP Back to Search Results
Device Problems Fluid/Blood Leak (1250); Material Perforation (2205); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/24/2014
Event Type  malfunction  
Event Description
The intra-aortic balloon pump was noted to be alarming with blood backing out from iabp tubing. The balloon pump was placed on standby and the balloon was emergently removed by the md, who found that the balloon had perforated. The maquet rep was called, who stated there will be an on- call technician to follow up. The catheter was sent via (b)(6) using the mailing pack and instructions provided by maquet.
 
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Type of DeviceCATHETER, INTRA-AORTIC BALLOON PUMP
Manufacturer (Section D)
MAQUET CARDIO VASCULAR LLC
45 barbour pond drive
wayne NJ 07470
MDR Report Key6053791
MDR Text Key58307718
Report Number6053791
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 09/22/2016,09/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/22/2016
Event Location Hospital
Date Report to Manufacturer09/22/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/25/2016 Patient Sequence Number: 1
Treatment
IABP SERIAL NUMBER (B)(4) AND CATHETER SERI; NO OTHER THERAPIES
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