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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW/TELEFLEX ARROW INTRAAORTIC BALLOON CATHETER ARROW IABP 7.5FR/40CC

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ARROW/TELEFLEX ARROW INTRAAORTIC BALLOON CATHETER ARROW IABP 7.5FR/40CC Back to Search Results
Device Problem Material Rupture (1546)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/04/2016
Event Type  Injury  
Event Description
Pt has multiple instances of arrow intra-aortic balloon pump rupture since original insertion on (b)(6) /2016. Dates of rupture and replacement as follows: on (b)(6) 2016 - initial insertion arrow 40; on (b)(6) 2016 - rupture with removal and new insertion arrow 30; on (b)(6) 2016 rupture with removal and reinsertion arrow 30; on (b)(6) 2016 rupture with removal and reinsertion. Massive r mca territory stroke with loss of grey-white matter differentiation.
 
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Brand NameARROW INTRAAORTIC BALLOON CATHETER
Type of DeviceARROW IABP 7.5FR/40CC
Manufacturer (Section D)
ARROW/TELEFLEX
reading PA 19605
MDR Report Key5885461
MDR Text Key52505099
Report NumberMW5064170
Device Sequence Number1
Product Code DSP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
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: 08/15/2016 Patient Sequence Number: 1
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