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

Catalog Number IAB-06840-U

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "after the balloon was placed normally, frequent alarms occurred after the machine had been working for some time, and after determining that the machine was normal, the balloon was found to be leaking after the catheter was withdrawn".A 2nd iab was not inserted.No patient harm or injury.The patient status is reported as "fine".

Event Description

It was reported that "after the balloon was placed normally, frequent alarms occurred after the machine had been working for some time, and after determining that the machine was normal, the balloon was found to be leaking after the catheter was withdrawn".A 2nd iab was not inserted.No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

(b)(4), the reported complaint for "balloon was found to be leaking" was confirmed upon the 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 ziplock bag (inp-1, inp-2).Upon return, the distal end of the teflon sheath was noted at approximately 26.8cm from the iabc distal tip (inp-4).The one-way valve was tethered to the short driveline tubing (inp-5).The bladder was fully unwrapped (inp-6).A bend to the iabc central lumen was noted at approximately 5.1cm from the iabc distal tip (np-7).A dried yellow media was noted on the exterior surfaces of the iabc.Dried blood was noted on the exterior of the iabc; no obvious blood was noted within the helium pathway.The iabc appeared to have been cleaned prior to return.The bladder thickness was measured at six points with measurements ranging from 0.0061in-0.0065in 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.The catheter's central lumen was successfully aspirated and flushed using a 60cc lab-inventory syringe.No blood or debris was noted.The iabc was leak tested using in accordance with testing methods from manufacturing procedure.Multiple leaks were immediately detected from the bladder membrane (anp-1).Upon further checking, two cuts/leak sites were noted on the iabc bladder and are consistent with contact from a sharp object (anp-2); these two leak sites were noted at approximately 24.8cm from the iabc distal tip.Three additional leak sites were noted on the bladder; under microscopic inspection, the leak sites are consistent with contact from a sharp object and were noted at approximately 24.3cm, 24.7cm and 25.2cm from the iabc distal tip (anp-3 through anp-5).No other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 5.2cm from the iabc distal tip, which is the location of the previously noted bend.The guidewire was able to advance through the central lumen.No blood or debris was noted.The guidewire was front loaded through the iabc luer.Resistance was noted at approximately 77.1cm from the iabc luer end, which is the location of the previously n oted bend.The guidewire was able to advance through the central lumen.No blood or debris was 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 in vestigation due to the bladder leaks.The root cause of the bladder leaks was undetermined.The most probable potential cause of how the catheter came into contact with a sharp object was customer handling.No further action required at this time.Teleflex will co ntinue to monitor and trend on reports of this nature.

• 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 Key: 18079479
• MDR Text Key: 328598652
• Report Number: 3010532612-2023-00626
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: 00801902026804
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• 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: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F23G0065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 55 KG