MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN039788
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that on the 5th day of iabp therapy, the nurse noted that there was blood in the helium pathway of the iab.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".
Event or Problem Description
It was reported that on the 5th day of iabp therapy, the nurse noted that there was blood in the helium pathway of the iab.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".
Additional Manufacturer Narrative
(b)(4).The reported complaint of iab blood in helium pathway was confirmed based upon the sample received.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 sealed ziploc bag (inp-1, inp-2).Returned with the sample was a non-teleflex 5ml syringe (inp-4).Upon return, the distal end of the teflon sheath was noted at approximately 33.2cm from the iabc distal tip; the teflon sheath hub as noted connected to the hemostasis cuff and dried/liquid blood was noted within the sheath sidearm (inp-4).The one-way valve was tethered to the short driveline tubing (inp-5).The supplied data-scope inflation driveline tubing was connected to the short driveline tubing; dried/liquid blood was noted within the returned inflation driveline tubing (inp-4, inp-5).The bladder was fully unwrapped (inp-6).Numerous bends to the iabc central lumen were noted at approximately 4.8cm, 31cm and 54.5cm from the iabc distal tip (inp-7, inp-8, and inp-9).The central lumen appeared damaged/broken at approximately 73.5cm from the iabc distal tip (inp-10).Dried blood was noted on the exterior surfaces of the returned iabc.Dried blood was noted within the iabc helium pathway.The customer photo was reviewed.The product identified in the photo matched the sample returned for the investigation.The photo showed blood within the helium pathway.This was consistent with the reported event.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 and pushback to the syringe was noted; the central lumen was likely blocked by dried blood.The iabc was leak tested in accordance with testing methods from manufacturing procedure.A leak was immediately detected from the iabc distal tip (anp-1).The leak from the iabc distal tip is consistent with the previously confirmed damaged/broken central lumen (inp-10).The iabc was leak tested again with the iabc distal tip blocked off; no other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 5cm and 54.2cm from the iabc distal tip, which are the locations of the previously noted bends.The guidewire could not advance at approximately 73.2cm from the iabc distal tip, which is the location of the previously noted damaged/broken central lumen.Some blood was noted on the guidewire.The guidewire was front loaded through the iabc luer.The guidewire could not advance at approximately 2.7cm from the iabc luer.Some 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 broken central lumen.The root cause of the broken central lumen is undetermined.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: ULTRAFLEX IAB: 7.5FR 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: 17152108
• Report Number: 3010532612-2023-00334
• Device Sequence Number: 14426371
• Product Code: DSP
• UDI-Device Identifier: 10801902145731
• UDI-Public: 10801902145731
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K000729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2023

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: 04/30/2024
• Device Model Number: IPN039788
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F22E0065
• 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: 05/29/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2022
• 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: Unknown