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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. 8 F 50 CC SENSATION PLUS IABP CATHETER (MAQUET) SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. 8 F 50 CC SENSATION PLUS IABP CATHETER (MAQUET) SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-1576-01U
Device Problem Coagulation in Device or Device Ingredient (1096)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 04/13/2021
Event Type  Injury  
Event Description
On (b)(6) 2021 at 1600, alarm condition "restriction" noted by bedside nurse, blood noted in the helium line by bedside rn. Iabp function ceased, (b)(6) notified of alarm and condition. Maquet contacted for troubleshooting. (b)(6) contacted. Patient transported to the cath lab for iab catheter removal. Cardiac surgeon was asked to assist removing required cutdown and removal with "significant resistance". Noted on removal significant debris inside the balloon pump itself; sent to pathology for evaluation. Pathology report reports material in the device was desiccated thrombus; repeated alarms day of removal for loos of gas; blood in tubing; the specimen is labeled with the patient's name and date of birth. The specimen consists of a 124. 3 cm in length by 0. 9 cm in greatest diameter medical device with plastic and metallic segments. Photographs are taken. There is a bag-like segment at one end that measures 26. 5 x 2. 6 x 0. 2 cm. There are is dried blood within the segment. At the end of this segment, there is a 0. 6 cm in greatest dimension plastic tip. Adjacent to the segment, is a 12 cm in length metallic segment with a clasp. Protruding off the clasp, there is a 20. 9 cm in length by 0. 3 cm in greatest diameter clear tube with blood within the tube with a clasp with yellow closures at the end. There is a 2nd segment of a plastic bag surrounding a metallic segment. Adjacent to this segment, there is a hard white plastic segment with a medical id that reads maquet sensation plus 8 fr. 500 cc. Protruding office white plastic segment, there is a cylindrical segment with a medical id that reads (b)(6). There is an additional protrusion off the white segment that has a 1. 9 cm in length metallic segment and a 7. 6 cm in length orange segment with a green yellowish fiber material protruding from the end. There is no tissue grossly identified. The specimen is for gross examination only. Fda safety report id # (b)(4).
 
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Brand Name8 F 50 CC SENSATION PLUS IABP CATHETER (MAQUET)
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
fairfield NJ 07004
MDR Report Key11706135
MDR Text Key247036879
Report NumberMW5100928
Device Sequence Number1
Product Code DSP
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 04/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-1576-01U
Device Catalogue Number0684-00-1576-01U
Device Lot Number30000141028
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/21/2021 Patient Sequence Number: 1
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