• 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 Entrapment of Device (1212); Fluid Leak (1250); Material Rupture (1546)
Patient Problems Injury (2348); Needle Stick/Puncture (2462); Device Embedded In Tissue or Plaque (3165)
Event Date 08/21/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the rn that the intra-aortic balloon (iab), fiber optic sensor (fos) pressures were not matching the pressures from the central lumen. The clinical support specialist (css), helped with calibrating the fos and the pressures are now correlating. The rn also reported to the css that the following day the intra-aortic balloon pump (iabp) started to alarm for helium loss 2 alarms. Soon after the alarms, the rn observed blood in the gas tubing. The physician was contacted immediately to remove the iab. The physician attempted to remove the iab through the sheath, rather than removing both together. Once the balloon was out of the sheath it was noticed that the tip of the balloon was missing. It had become detached when the balloon was pulled through the sheath. The patient was taken emergently to the or to retrieve the tip. As a result, the tip was successfully removed and repair to the right femoral artery. A second iab was successfully inserted into the left femoral artery. The patient is now stable on the balloon pump. There was a report of serious injury but not death.
 
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 Key9008595
MDR Text Key157825905
Report Number3010532612-2019-00316
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 08/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2020
Device Catalogue NumberIAB-05830-LWS
Device Lot Number18F18L0001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/12/2019 Patient Sequence Number: 1
Treatment
MINIMAL SUPPORT ON VASOACTIVE DRUGS.
-
-