MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ULTRAFLEX IAB: 7.5FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-06830-U

Device Problem Entrapment of Device (1212)

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

Event Date 12/26/2023

Event Type  malfunction  

Event Description

It was reported " the balloon was placed using a sheath with a lateral arm, which was obstructed during balloon pushing and could not advance, and after trying other methods, it still could not pass through the sheath.The balloon was withdrawn, but the balloon could not be withdrawn from the sheath, and the sheath was removed at the same time as the balloon.The balloon was replaced with a new one, and the placement was normal." second device placed within same insertion site.No patient injury or consequence reported.Patient's current condition reported as "fine".

Manufacturer Narrative

(b)(4).

Event Description

It was reported " the balloon was placed using a sheath with a lateral arm, which was obstructed during balloon pushing and could not advance, and after trying other methods, it still could not pass through the sheath.The balloon was withdrawn, but the balloon could not be withdrawn from the sheath, and the sheath was removed at the same time as the balloon.The balloon was replaced with a new one, and the placement was normal." second device placed within same insertion site.No patient injury or consequence reported.Patient's current condition reported as "fine".

Manufacturer Narrative

(b)(4).The reported complaint of iab catheter stuck in sheath was confirmed upon investigation of the returned sample.The customer returned a 30cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) with the original packaging that matches the serial number on the returned sample (inp-2, inp-4) for investigation.The sample was returned in a cardboard box and was loosely packed within the original packaging carton (inp-1, inp-5).Returned with the sample was supplied kit components including 30cc inflation driveline tubing and a 0.025in guidewire; no damage or abnormalities were noted to the returned components (inp-6).Upon return, the teflon sheath was noted on the iabc bladder (inp-6, inp-8).The distal end of the teflon sheath was noted at approximately 3.5cm from the iabc distal tip; liquid blood was noted within the sheath sidearm (inp-6, inp-8, and inp-9).The one-way valve was tethered to the short driveline tubing (inp-7).Ther supplied data-scope inflation driveline tubing was noted connected to the short driveline tubing; no damage or abnormalities were noted (inp-7).The exposed portion of the bladder was noted slightly unwrapped (inp-9).A slight bend to the iabc central lumen was noted at approximately 9.8cm from the iabc distal tip (inp-6, inp-8).Dried 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 0.0062in-0.0067in 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 iabc central lumen was successfully aspirated and flushed using a 60cc lab-inventory syringe.Some blood exited.The one-way valve was connected to the short driveline tubing and vacuum was pulled on the iabc.While maintaining the vacuum, the sheath was removed from the bladder without any difficulty.The bladder appeared typical; no damage or abnormalities were noted to the bladder (anp-1).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.No resistance was noted; the guidewire was able to advance through the central lumen.Some blood was noted on 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.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 bent central lumen.The root cause of the complaint was undetermined.A most probable potential root cause is customer handling.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: ARROW 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18672749
• MDR Text Key: 334998529
• Report Number: 3010532612-2024-00107
• Device Sequence Number: 1
• Product Code: DSP
• 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,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F23K0061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2023
• 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: 73 YR
• Patient Sex: Male
• Patient Race: White