• 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 30CC SYSTEM, BALLOON, INTRA-AORTIC

  • 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 30CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-05830-LWS
Device Problems Material Rupture (1546); Gas Leak (2946)
Patient Problems No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462)
Event Date 10/20/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Other remarks: for complaints involving the same patient and event see: mdr #3010532612-2019-00397 and (b)(4), mdr #3010532612-2019-00398 and (b)(4), mdr #3010532612-2019-00396 and (b)(4).
 
Event Description
It was reported by the rn that the intra-aortic balloon pump (iabp) has constant helium loss alarms. The rn called the hotline to discuss the helium loss alarms. The intra-aortic balloon (iab) was inserted in the cath lab and removed immediately due to "so much calcification that the iab was shredded". There was no blood noted in the tubing, helium loss alarms less than 2 minutes apart. A leak test was performed and the iab failed the test. The iabp was exchanged as well as the helium tanks. As a result, the surgeon opted to not reinsert as the patient is stable and "doing well". It was reported that for the fourth iab insertion the md used the opposite groin. The patient was reported to be stable off the iabp. There was no report of patient complications or consequence.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 30CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key9309944
MDR Text Key166933371
Report Number3010532612-2019-00399
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,Followup
Report Date 10/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberIAB-05830-LWS
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2019
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

-
-