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

Catalog Number IAB-06830-U

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 04/03/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported " the pump was turned on after placement of the tube and could not be counterpulsed, then the doctor decided to withdraw it and reactivate a set of supplies on the same side, which worked normally.Flushing the central lumen revealed that the central lumen had broken off and water had gotten into the balloon".To continue therapy,the iab catheter was removed and replaced using the same insertion site.No patient harm or injury reported.The patient's current condition is reported as "fine".

Manufacturer Narrative

Qn #: (b)(4).Returned for investigation was a 30cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) with the original packaging that matches the serial number for the returned sample.Returned with the sample was the supplied 30cc driveline tubing, a 60cc syringe, and the long and short arterial pressure tubing.Upon return, the peel away sheath was noted connected to the hemostasis cuff.The one-way valve was tethered and connected 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/polyimide (part of the flex tip assembly) was noted partially separated from the inner cannula (iabc central lumen) at approximately 5cm from the iabc distal tip.No obvious blood was noted on the iabc or within the helium pathway; the catheter was likely cleaned prior to return.Upon return, the original packaging tray was immediately noted with damage to the "arrow" packaging sticker which retains the iabc bladder in the packaging tray.The arrow sticker was noted cut/ripped and a portion of the sticker was completely missing.This packaging sticker is not to be removed.Since damage to the "arrow" packaging sticker was noted, which indicates that the catheter was not prepped per the instructions for use (ifu), an in-service has been requested to review the instructions for use (ifu) with the customer.The instructions for use (ifu) states: "1.Connect one-way valve to male luer on short driveline tubing attached to iab.Insert supplied syringe into one-way valve.Slowly aspirate a full syringe of air.Precaution: the one-way valve will maintain vacuum on the balloon and must remain in place until is fully inserted.Remove syringe.2.Remove catheter from tray, keeping it in line with balloon membrane.3.Grasp catheter close to tray and pull it straight out of the holding sleeve.Note: keep catheter level with tray.Do not lift or bend during removal." the customer photo was reviewed.The photo shows a damaged central lumen which is consistent with the reported event.The bladder thickness was measured at six points with measurements ranging from 0.0054in-0.0061in and was within specification.The one-way valve was tested and failed.A vacuum was pulled on the one-way valve, and it immediately lost pressure.This was repeated five separate times.The one-way valve was properly cleaned and tested again; the one-way valve 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 central lumen.The iabc was leak tested again with the iabc distal tip and luer end blocked off; no other leaks were detected.A lab inventory 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 flex-tip assembly separation.No blood and 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 for "flushing the central lumen revealed that the central lumen had broken off" is confirmed.During the investigation , the intra-aortic balloon catheter (iabc) central lumen was noted broken in the flex-tip assembly area near the iabc distal tip.Unrelated to the reported complaint, the original packaging tray was noted with damage to the "arrow" packaging sticker, which indicates a potential that the catheter was not prepped per the instructions for use (ifu) and can result in damage to the catheter.As a result, an in-service has been requested to review the instructions for use (ifu) with the customer.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 root cause of the complaint is undetermined.A corrective and preventive action has been initiated to further investigate the issue.

Event Description

It was reported "the pump was turned on after placement of the tube and could not be counterpulsed, then the doctor decided to withdraw it and reactivate a set of supplies on the same side, which worked normally.Flushing the central lumen revealed that the central lumen had broken off and water had gotten into the balloon".To continue therapy,the iab catheter was removed and replaced using the same insertion site.No patient harm or injury reported.The patient's current condition is reported as "fine".

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19209215
• MDR Text Key: 341472133
• Report Number: 3010532612-2024-00320
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902003751
• UDI-Public: 00801902003751
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

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
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F23M0055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2024
• 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
• Treatment: N/A.; N/A.
• Patient Age: 60 YR
• Patient Sex: Female