Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 ARROW ULTRAFLEX IAB: 7.5FR 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 ARROW ULTRAFLEX IAB: 7.5FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-06830-U
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/05/2024
Event Type  malfunction  
Event Description
It was reported " the balloon is not pacing and is not functioning properly".To continue therapy the deviced was replaced and was inserted unsing the same insertion site.No patient injury or consequence reported.The patient's current condition is reported as "fine".
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Qn#(b)(4).Returned for investigation was a 30cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging.Upon return, the peel away sheath was noted connected to the hemostasis cuff.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.A bend to the iabc central lumen was noted at approximately 29cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned sample.No obvious blood was noted within the helium pathway.The one-way valve was tested and passed.A vacuum was pulled on the one-way valve, and it held for at least 1 minute and then 30 seconds five separate times.An attempt to aspirate and flush the iabc central lumen using a 60cc lab-inventory syringe was unable to be successfully completed.Upon aspiration, water was unable to be consistently pulled into the syringe.The iabc was leak tested and an external leak was immediately noted and located around the bifurcate bushing bond.Upon further inspection, the leak occurred from the adhesive bond at the bifurcate bushing.No other leaks were detected.A lab inventory 0.025in guidewire was back loaded through iabc distal tip.No resistance was noted; the guidewire was able to advance through the central lumen.No blood or debris was noted on the guidewire upon removal.The guidewire was front loaded through the iabc luer.No resistance was noted; the guidewire was able to advance through the central lumen.No blood or debris was noted on the guidewire upon removal.An attempt to aspirate and flush the catheter using a 60cc lab inventory syringe was unable to be successfully completed before inserting the guidewire.Another attempt to aspirate and flush the catheter was successfully completed.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint for iab leak suspected is confirmed.During the investigation, an external leak was confirmed from the intra-aortic balloon catheter (iabc) bifurcate bushing adhesive.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the external leak from the iabc bifurcate bushing adhesive.The probable root cause is manufacturing related.A non-conformance has been initiated to further investigate the issue.
 
Event Description
It was reported " the balloon is not pacing and is not functioning properly".To continue therapy the deviced was replaced and was inserted unsing the same insertion site.No patient injury or consequence reported.The patient's current condition is reported as "fine".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ARROW ULTRAFLEX IAB: 7.5FR 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 Key19006619
MDR Text Key338985093
Report Number3010532612-2024-00222
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902003751
UDI-Public00801902003751
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K000729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberIAB-06830-U
Device Lot Number18F23B0020
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2024
Is the Reporter a Health Professional? No
Date Manufacturer Received04/12/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/10/2023
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 Age64 YR
Patient SexMale
Patient Weight72 KG
-
-