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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 7.5FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 7.5FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-06830-U
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/26/2023
Event Type  malfunction  
Event Description
It was reported that "during the operation, the balloon was found kinked." as a result, the iab was removed and a 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".
 
Manufacturer Narrative
Qn#(b)(4).
 
Manufacturer Narrative
Qn#(b)(4).No serial number was reported.The serial number on the returned sample is (b)(6).The reported lot number (18f23b0020) matches the lot number for the returned sample and packaging.Returned for investigation was a 30cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) with the original packaging that matches the serial number of the returned iabc.The sample was returned in a cardboard box and was loosely packed within the original packaging carton.Returned with the sample were components: one 0.025in guidewire, scalpel, short ap tubing, pre-dilator, dilator, dilator/teflon sheath assembly, 60cc syringe, and a teflon sheath w/sidearm.Upon return, it was noted that the teflon sheath w/ sidearm was found with blood and there was sheath buckling noted from approximately 14.2cm to 15cm from the sheath tip.The sheath tip was also noted slightly damaged.There is no evidence to confirm this finding is related to the complaint or same event and the potential cause is customer handling.No other abnormalities were noted to the returned components.The returned 0.025in guidewire was inspected and appeared typical.Upon return, the peel-away sheath was on the iabc.The supplied 30cc inflation driveline tubing was connected to the iabc short driveline tubing; no blood was noted within the tubing and no abnormality was noted.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.The iabc central lumen within the flex-tip assembly area was noted damaged; the wire round was unraveled, and the polyimide (part of the flex tip assembly) was noted no longer attached and separated from the inner cannula (iabc central lumen) at approximately 5.9cm 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 attempt to flush resulted in bladder inflation.The results are consistent with the previously noted damaged central lumen.The iabc was leak tested and a leak was immediately detected from the iabc distal tip and iabc luer end.The leak from the iabc distal tip and iabc luer end are consistent with the previously confirmed damaged/separated central lumen.The iabc was leak tested again with the iabc distal tip and iabc luer end blocked off; no other leaks were detected.The returned 0.025in guidewire was back loaded through the iabc distal tip.The guidewire exited the central lumen and entered the bladder at the location of the flex-tip assembly separation.No blood or debris was noted.The guidewire was front loaded through the iabc luer.The guidewire exited the central lumen and entered the bladder at the location of the inner cannula separation.No blood or debris was noted.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 that the "balloon was found kinked" is confirmed.During the investigation, the iabc central lumen was noted damaged and found no longer attached to the central lumen flex tip assembly.The damaged central lumen could be consistent with a kink, or the initial kink may have resulted in further damage to the central lumen.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 probable root cause of the complaint is undetermined.A non-conformance has been initiated to further investigate the issue.
 
Event Description
It was reported that "during the operation, the balloon was found kinked." as a result, the iab was removed and a 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".
 
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Brand Name
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 Key17557112
MDR Text Key321274269
Report Number3010532612-2023-00464
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902136701
UDI-Public00801902136701
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,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/31/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberIAB-06830-U
Device Lot Number18F23B0020
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received09/19/2023
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
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