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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 Problems Flushing Problem (1252); 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 had multiple instances of arrow intra-aortic balloon pump rupture since original insertion on (b)(6) 2016. Dates of rupture and replacement as follows: (b)(6) 2016 - initial insertion arrow 40; (b)(6) 2016 - repositioning of catheter; (b)(6) 2016 - removal and reinsertion arrow 40 (2 separate catheters - first one would not flush so was pulled and new one put in); (b)(6) 2016 - rupture with removal and reinsertion arrow 40; (b)(6)2016 - rupture with removal and re insertion 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 Key5888304
MDR Text Key52627622
Report NumberMW5064178
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
4 Devices were Involved in the Event: 1   2   3   4  
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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