• 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 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 30CC INTRA- AORTIC BALLOON FIBER OPTIC Back to Search Results
Catalog Number IAB-05830-LWS
Device Problems Device Alarm System (1012); Fluid Leak (1250)
Patient Problem Venipuncture (2129)
Event Date 09/12/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Teleflex received the device for investigation. The reported complaint of blood in helium pathway is confirmed. Two cuts consistent with contact from a sharp object were found on the bladder membrane which likely allowed blood to enter the helium pathway. The root cause of the bladder damage is undetermined. A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings. The device passed all manufacturing specifications prior to release. This issue will be monitored for any developing trends. No further action required at this time.
 
Event Description
It has been reported that the staff noticed blood in the intra-aortic balloon catheter (iabc) drive line when therapy was being delivered. Once the blood was noticed, pumping was stopped. As a result, the catheter was removed surgically. The pump alarmed kinked catheter. Patient outcome: reported as "fine". The intra-aortic balloon (iab) was not replaced with another iab. No reported patient death.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It has been reported that the staff noticed blood in the intra-aortic balloon catheter (iabc) drive line when therapy was being delivered. Once the blood was noticed, pumping was stopped. As a result, the catheter was removed surgically. The pump alarmed kinked catheter. Patient outcome: reported as "fine". The intra-aortic balloon (iab) was not replaced with another iab. No reported patient death.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 30CC
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
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key6930198
MDR Text Key134608565
Report Number1219856-2017-00222
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 09/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2019
Device Catalogue NumberIAB-05830-LWS
Device Lot Number18F17D0026
Other Device ID Number00801902034724
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/12/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-