MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN039785
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reported as "blood noted in the helium driveline".It was reported that "[the user] called regarding 2 alarms.She was unable to recall the exact alarm, but endorsed the pump stopped with each.She had noted the cl was dampened and flushed.She requested to verify the bpw was appropriate.Bpw and aug within 25mmhgat this time.I asked if there was blood in the driveline.[the user] stated, 'just iodine or betadine on the line.' pump paused.Eva cleaned driveline.Flecks remained present in helium tubing.No flecks near iabp.Iab removal recommended.[the user] endorsed md was on the way already to remove as planned and will inform him of ruptured iab." as a result, the iab was removed intact and without difficulty.No visible clots or bleeding issues noted upon removal.A 2nd iab was not inserted.No patient harm or injury.The patient status is reported as "stable".
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
(b)(4).The reported complaint for iab "blood noted in helium driveline" was not able to be confirmed as 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 was undetermined.No further actions were required at this time.Teleflex will continue to monitor and trend for complaints of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
Reported as "blood noted in the helium driveline".It was reported that "[the user] called regarding 2 alarms.She was unable to recall the exact alarm, but endorsed the pump stopped with each.She had noted the cl was dampened and flushed.She requested to verify the bpw was appropriate.Bpw and aug within 25mmhgat this time.I asked if there was blood in the driveline.[the user] stated, 'just iodine or betadine on the line.' pump paused.Eva cleaned driveline.Flecks remained present in helium tubing.No flecks near iabp.Iab removal recommended.[the user] endorsed md was on the way already to remove as planned and will inform him of ruptured iab." as a result, the iab was removed intact and without difficulty.No visible clots or bleeding issues noted upon removal.A 2nd iab was not inserted.No patient harm or injury.The patient status is reported as "stable".
Additional Manufacturer Narrative
(b)(4).The reported complaint that "blood noted in helium driveline" was confirmed based upon the sample received.The customer returned a 40cc 8fr ultra intra-aortic balloon catheter (iabc) without the original packaging for investigation.The sample was returned in the supplied return kit and was in a sealed bio-hazard bag (inp-1, inp-2).Returned with the sample was the supplied 40cc driveline tubing; some dried blood was noted within the tubing (inp-6).Upon return, the distal end of the teflon sheath was at approximately 29.4cm from the iabc distal tip; fluid was noted within the sheath sidearm (inp-7).The teflon sheath hub was noted connected to the hemostasis cuff (inp-5, inp-7).The one-way valve was tethered to the short driveline tubing (inp-4).A section of the supplied arterial pressure assembly was noted connected to the iabc luer; liquid blood was noted within the ap tubing (inp-4).The bladder was fully unwrapped (inp-8).Bends to the iabc central lumen were noted at approximately 20.8cm, 36.5cm, and 72cm from the iabc distal tip (inp-9, inp-10, inp-11).Dried blood was noted on the exterior surfaces of the returned sample.Dried blood was noted within the bladder/helium pathway.The bladder thickness was measured at six points with measurements ranging from 0.0056in-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.A leak was immediately detected from the bladder membrane (anp-1).Under microscopic inspection, abrasions were observed from approximately 9cm to 9.7cm from the iabc distal tip (anp-2).A full thickness abrasion to the bladder was confirmed at approximately 9.2cm from the iabc distal tip and the appearance was consistent with repeated contact with calcified plaque on the aortic wall (anp-3).No other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.The guidewire met resistance and could not advance at approximately 4.7cm from the iabc distal tip due to a blocked central lumen.Blood was noted on the guidewire.The central lumen was likely blocked by dried blood.The guidewire was front loaded through the iabc luer.The guidewire met resistance and could not advance at approximately 9.2cm from the iabc luer due to a blocked central lumen.Blood was noted on the guidewire.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 bladder leak.The root cause of the bladder leak is related to patient condition.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
Reported as "blood noted in the helium driveline".It was reported that "[the user] called regarding 2 alarms.She was unable to recall the exact alarm, but endorsed the pump stopped with each.She had noted the cl was dampened and flushed.She requested to verify the bpw was appropriate.Bpw and aug within 25mmhgat this time.I asked if there was blood in the driveline.[the user] stated, 'just iodine or betadine on the line.' pump paused.(b)(6) cleaned driveline.Flecks remained present in helium tubing.No flecks near iabp.Iab removal recommended.[the user] endorsed md was on the way already to remove as planned and will inform him of ruptured iab." as a result, the iab was removed intact and without difficulty.No visible clots or bleeding issues noted upon removal.A 2nd iab was not inserted.No patient harm or injury.The patient status is reported as "stable".

• Brand Name: ULTRA 8 IAB: 8FR 40CC
• Common Device Name: 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 Key: 17351541
• Report Number: 3010532612-2023-00394
• Device Sequence Number: 6091589
• Product Code: DSP
• UDI-Device Identifier: 10801902145670
• UDI-Public: 10801902145670
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K000729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: IPN039785
• Device Catalogue Number: IAB-05840-U
• Device Lot Number: 18F23A0060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 08/17/2023; 10/30/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 08/21/2023; 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 87 KG