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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW/TELEFLEX ARROW INTRA-AORTIC BALLOON CATHETER ARROW IABP 40CC

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ARROW/TELEFLEX ARROW INTRA-AORTIC BALLOON CATHETER ARROW IABP 40CC Back to Search Results
Device Problem Material Rupture (1546)
Patient Problem No Code Available (3191)
Event Date 08/15/2016
Event Type  Injury  
Event Description
Pt has had arrow intra-aortic balloon pump rupture. Dates of rupture and replacement as follows: (b)(6) 2016 - insertion of iabp (femoral) arrow 40 (b)(6) 2016 - removal of femoral iabp, insertion of axillary iabp arrow 40 (b)(6) 2016 - rupture and reinsertion arrow 40.
 
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Brand NameARROW INTRA-AORTIC BALLOON CATHETER
Type of DeviceARROW IABP 40CC
Manufacturer (Section D)
ARROW/TELEFLEX
reading PA 19605
MDR Report Key5888303
MDR Text Key52621566
Report NumberMW5064177
Device Sequence Number1
Product Code DSP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 08/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2016
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: 08/16/2016 Patient Sequence Number: 1
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