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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERVENTIONAL, INC. (SUBSIDIARY OF ARROW INTL, INC) FIBEROPTIX; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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ARROW INTERVENTIONAL, INC. (SUBSIDIARY OF ARROW INTL, INC) FIBEROPTIX; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number IAB-05840-LWS
Device Problems Device Alarm System (1012); Material Rupture (1546); Physical Resistance (2578)
Patient Problems Hemorrhage/Bleeding (1888); No Known Impact Or Consequence To Patient (2692)
Event Date 10/03/2014
Event Type  Injury  
Event Description
Patient required the use of an intra-aortic balloon pump (iabp).An iabp sheath was placed in the left femoral artery, then an iabp balloon was inserted and positioned in the descending aorta and counterpulsation was initiated.The iabp had been functioning without problem until the following afternoon when blood was noted within the balloon tubing, indicating a rupture.The balloon pump had continued functioning without alarming but the balloon waveform was noted to inflate and drop off quickly.The iabp was turned off and an attempt was made to remove the balloon, but resistance to pull was noted.The patient required vascular surgical intervention to remove the ruptured balloon.
 
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Brand Name
FIBEROPTIX
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
ARROW INTERVENTIONAL, INC. (SUBSIDIARY OF ARROW INTL, INC)
9 plymouth street
everett MA 02149
MDR Report Key4735600
MDR Text Key22056527
Report Number4735600
Device Sequence Number1
Product Code DSP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 10/21/2014
1 Device was Involved in the Event
2 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Invalid Data
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F14H0030
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Event Location Hospital
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/23/2015
Patient Sequence Number1
Treatment
SERVICE, EVALUATED, AND FOUND TO BE FUNCTIONING; INTRA-AORTIC BALLOON PUMP WHICH WAS REMOVED FROM; APPROPRIATELY.
Patient Outcome(s) Hospitalization; Required Intervention; Disability;
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