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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH UNKNOWN IABP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Type  Death  
Manufacturer Narrative
No additional information is available for this event as the article does not provide any contact information on the author. In addition, the article did not provide information on the manufacturer of the iabp, pump model or serial number.
 
Event Description
The following was reported via an article reviewed by getinge: an (b)(6) year old male with a past medical history of peripheral artery disease with bilateral iliac stents, paroxysmal atrial fibrillation and ischemic cardiomyopathy presented to the emergency room with lightheadedness and palpitations. Presenting vital signs revealed a blood pressure of 144/75 mmhg, heart rate of 130 bpm and oxygen saturation 95% on room air. On physical exam he was noted to be diaphoretic and in distress. His ecg revealed ventricular tachycardia. He was treated with intravenous metoprolol tartrate, amiodarone 300 mg intravenous and subsequently required successful synchronized electrical cardioversion with 150 joules. Coronary angiogram was performed which showed triple vessel cad (90¿95% proximal rca, in-stent restenosis of mid rca with severe diffuse disease, 70¿80% mid-left anterior descending [mlad] and chronic total occlusion of left circumflex artery). Decision was made to perform pci of the mlad which was complicated by perforation requiring occlusive stent and subsequent iabp placement. During cautious attempt on removal of the iabp resistance was met due to the entrapment of the balloon to the right iliac stent (figure 3). Under fluoroscopic guidance, removal using a leftto-right femoral visualization assistance technique was used. This was complicated by thrombotic occlusion of the right distal superficial femoral artery possibly secondary tomechanical manipulation resulting in distal embolization (figure 4). Recanalization and balloon angioplasty of the lesion was successfully performed, and adequate flow was established. Hemostasis of the right groin access was achieved with manual pressure. After removal of the iabp, the right lower extremity was warm however, distal pulses could not be appreciated with doppler. Patient was maintained on aspirin, clopidogrel and heparin infusion, and planned for repeat peripheral angiography of lower extremities. Subsequently in the ccu he developed st-elevation on telemetry and ultimately expired, likely from closure of the mlad stent.
 
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Brand NameUNKNOWN IABP
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key10453728
MDR Text Key204360872
Report Number2249723-2020-01343
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2020
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: 08/26/2020 Patient Sequence Number: 1
Treatment
UNKNOWN IAB
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