• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC INTRA- AORTIC BALLOON FIBER OPTIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC INTRA- AORTIC BALLOON FIBER OPTIC Back to Search Results
Catalog Number IAB-05840-LWS
Device Problems Unable to Obtain Readings (1516); Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/06/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). It was reported by the rn and the medical doctor that the iab and iabp were not the cause of the patient's death. It was stated in the reported complaint that the catheter was discarded and therefore not returned to teleflex to be investigated. Other remarks: see mdr# 1219856-2016-00282/1900049681 for other report.
 
Event Description
It was reported via a hot line call. According to the registered nurse (rn) in the cath lab they had inserted one catheter and removed it prior to speaking to the clinical support specialist. According to the rn the fiber optic arterial line (a-line) would not zero. As a result, a second intra-aortic balloon ((b)(4)) was inserted. The patient is critical.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 40CC
Type of DeviceINTRA- AORTIC BALLOON FIBER OPTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
carmen sherman
3015 carrington mill blvd
morrisville 27560
MDR Report Key6220217
MDR Text Key63807729
Report Number1219856-2016-00283
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAB-05840-LWS
Other Device ID Number00801902007247
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-