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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-06840-U
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/20/2023
Event Type  malfunction  
Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
 
Event Description
It was reported that "the front end of the catheter is folded and cannot insert".As a result, the iab was removed.A 2nd iab was not inserted.No patient harm or injury.The patient status is reported as "fine".
 
Event Description
It was reported that "the front end of the catheter is folded and cannot insert".As a result, the iab was removed.A 2nd iab was not inserted.No patient harm or injury.The patient status is reported as "fine.".
 
Manufacturer Narrative
Qn# (b)(4).The reported complaint that the "front end of the catheter is folded and cannot insert" 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.The sample was returned in a cardboard box and was in a clear pouch (inp-1, inp-2).Upon return, the one-way valve was tethered to the short driveline tubing (inp-6).The bladder was fully unwrapped (inp-7).Numerous bends to the iabc central lumen were noted at approximately 5.5cm, 11.6cm, 25cm, 35.3cm and 74.5cm from the distal tip (inp-8 through inp-12).No blood was noted on the exterior surfaces of the returned iabc; no blood was noted within the helium pathway.The bladder thickness was measured at six points with measurements ranging from 0.0054in-0.0061in and was within specification of process document.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 according to quality system document.An attempt to aspirate and flush the catheter using a 60cc lab-inventory syringe was unable to be successfully completed due to a blocked central lumen.Immediate push back on the syringe plunger was experienced.The blockage was most likely dried blood.The iabc was leak tested in accordance with testing methods from manufacturing procedure.No leaks were detected.Full inflation was achieved.The device passed the leak test.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 4.8cm, 7.4cm, 10.6cm, 23.4cm, 37.3cm, 42.1cm, 60cm and 73.9cm from the iabc distal tip.The guidewire was able to advance through the central lumen with force required.Blood clot exited with the guidewire.The guidewire was front loaded through the iabc luer.No resistance was noted; the guidewire was able to advance through the central lumen.Blood noted on the guidewire.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, after clearing blood clot from the central lumen during the guidewire test.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 bent central lumen.The root cause of the complaint was undetermined.No further action required at this time.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
 
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Brand Name
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 Key18478343
MDR Text Key332989689
Report Number3010532612-2024-00042
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902026804
UDI-Public00801902026804
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,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2024
Device Catalogue NumberIAB-06840-U
Device Lot Number18F22C0074
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2024
Is the Reporter a Health Professional? No
Date Manufacturer Received02/14/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/29/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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