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

Catalog Number IAB-06840-U

Device Problem Leak/Splash (1354)

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

Event Date 03/07/2024

Event Type  malfunction  

Event Description

It was reported "in the midst of a balloon puncture into the body, the balloon fractured and ruptured and could not be delivered to the aorta".To continue therapy, another cathheter was inserted using the same insertion site.No patient injury or consequence reported.The patient's current condition is reported as "fine".

Manufacturer Narrative

(b)(4).

Event Description

It was reported "in the midst of a balloon puncture into the body, the balloon fractured and ruptured and could not be delivered to the aorta".To continue therapy, another cathheter was inserted using the same insertion site.No patient injury or consequence reported.The patient's current condition is reported as "fine".

Manufacturer Narrative

Qn#(b)(4).Returned for investigation was a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging.The bladder was fully unwrapped.The iabc central lumen within the flex-tip assembly area was noted damaged; the flex tip assembly was noted no longer attached and separated from the inner cannula (iabc central lumen) at approximately 6.5cm from the iabc distal tip.A bend to the iabc was noted at approximately 59.8cm from the iabc luer.Dried blood was noted on the exterior surfaces of the returned sample.Some dried blood was noted within the bladder/helium pathway.No other visual damage or abnormalities were noted to the returned iabc/bladder.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.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 the bladder inflation.The results are consistent with the previously confirmed damaged/separated central lumen.The iabc was leak tested and a leak was immediately detected from the iabc distal tip and luer end.The leak from the iabc distal tip and luer end are consistent with the previously confirmed damaged/separated central lumen.The iabc was leak tested again with the iabc distal tip and luer end blocked off; no other leaks were detected.The returned 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.Resistance was noted at approximately 59.8cm from the iabc luer, which is the location of the previously noted bend.Then the guidewire exited the central lumen and entered the bladder at the location of the inner cannula separation.Some blood was exited with the guidewire.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 that the "balloon fractured and ruptured and could not be delivered to the aorta" is confirmed.During the investigation, the iabc central lumen was noted damaged and found no longer attached to the central lumen flex tip assembly.The damaged central lumen can result in difficulty inserting the iabc into the patient.The returned intra-aortic balloon catheter (iabc) bladder was fully intact with no damage 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 investigation due to the damaged central lumen.The root cause of the complaint is undetermined.A corrective and preventive action (capa) has been initiated to further investigate the issue.

• Brand Name: ARROW 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19010456
• MDR Text Key: 338992252
• Report Number: 3010532612-2024-00218
• 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,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F23E0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2023
• 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