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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL LLC ARROW ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-06840-U
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/30/2024
Event Type  malfunction  
Event Description
It was reported "device alarmed for helium leak.The catheter was not found to be fractured, and the device was tested with a simulator; the device did not alarm.There was blood on the inside of the anterior section of the catheter near the marked spot, presumably the catheter was leaking".The catheter was removed and replaced in the same insertion site to complete the procedure.No patient injury or consequence reported.Patient's current condition reported as "fine".
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4).The reported complaint that "device alarmed for helium leak" was confirmed upon investigation of the returned sample.The customer returned a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging for investigation along with the arterial pressure tubing and a driveline tubing; a connector was noted missing from the driveline tubing.Upon return, dried blood was noted within the sheath sidearm and on the exterior surfaces of the returned sample.No blood was noted within the bladder/helium pathway.The intra-aortic balloon catheter (iabc) central lumen was noted damaged within the iabc flex-tip assembly area and a cross-over leak was confirmed; this can result in helium loss alarms.The returned iabc bladder membrane was fully intact, with no leaks noted.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 damaged central lumen.The root cause of the complaint was undetermined.A capa has been initiated under teleflex's quality systems to further investigate the issue.
 
Event Description
It was reported "device alarmed for helium leak.The catheter was not found to be fractured, and the device was tested with a simulator; the device did not alarm.There was blood on the inside of the anterior section of the catheter near the marked spot, presumably the catheter was leaking".The catheter was removed and replaced in the same insertion site to complete the procedure.No patient injury or consequence reported.Patient's current condition reported as "fine".
 
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Brand Name
ARROW ULTRAFLEX IAB: 7.5FR 40CC
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
kevin don bosco
3015 carrington mill blvd
morrisville 27560
MDR Report Key18744044
MDR Text Key335843652
Report Number3010532612-2024-00126
Device Sequence Number1
Product Code DSP
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 02/05/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberIAB-06840-U
Device Lot Number18F23H0075
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/05/2024
Initial Date FDA Received02/20/2024
Supplement Dates Manufacturer Received03/26/2024
Supplement Dates FDA Received03/27/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/26/2023
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 SexMale
Patient Weight71 KG
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