• 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 LLC 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 LLC FIBEROPTIX ULTRA 8 IAB: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-05830-LWS
Device Problem Fluid/Blood Leak (1250)
Patient Problems Needle Stick/Puncture (2462); Cardiac Perforation (2513)
Event Date 06/13/2023
Event Type  Injury  
Manufacturer Narrative
(b)(4).Medwatch # (b)(4).Other remarks: n/a.Corrected data: n/a.
 
Event Description
It was reported via a medwatch report that after insertion of the iab, "the tubing started to back-fill with blood; the balloon pump was then removed and a hole was noted in the balloon at that time.When the balloon was removed the femoral artery was torn requiring a vascular surgeon to come in to repair the left femoral artery".Additional information states that "when withdrawing it the team didn't deflate sufficiently and therefore caused the tear in aorta.Patient post-primary repair of (l) common femoral artery and to icu in stable condition." as a result, a 2nd iab was inserted at a different insertion site.
 
Manufacturer Narrative
(b)(4).The reported complaint that the "tubing started to back-fill with blood and a hole was noted in the balloon" is not able to be confirmed.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.
 
Event Description
It was reported via a medwatch report that after insertion of the iab, "the tubing started to back-fill with blood; the balloon pump was then removed and a hole was noted in the balloon at that time.When the balloon was removed the femoral artery was torn requiring a vascular surgeon to come in to repair the left femoral artery".Additional information states that "when withdrawing it the team didn't deflate sufficiently and therefore caused the tear in aorta.Patient post-primary repair of (l) common femoral artery and to icu in stable condition." as a result, a 2nd iab was inserted at a different insertion site.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FIBEROPTIX ULTRA 8 IAB: 8FR 30CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key17567773
MDR Text Key321385334
Report Number3010532612-2023-00470
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902034724
UDI-Public00801902034724
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 Other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2023
Device Catalogue NumberIAB-05830-LWS
Device Lot Number18F21L0004
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/02/2023
Initial Date FDA Received08/17/2023
Supplement Dates Manufacturer Received09/21/2023
Supplement Dates FDA Received09/28/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/02/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age72 YR
Patient SexFemale
Patient Weight69 KG
-
-