MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-05840-LWS
Medical Device Problem Codes	Burst Container or Vessel (1074); Inflation Problem (1310)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that after the iab was inserted and pumping was started, the pump alarmed for "high pressure".The patient was imaged under fluoroscopy, the balloon did not inflate completely.Troubleshooting was attempted however it was determined to remove the iab.After the iab was removed, it was seen that balloon was "faulty".Another attempt was not made as "no spare iac due to constraint.The patient was referred to a bigger center for ivs rupture surgery".No patient harm or injury.At the time of this report the customer has not returned our requests or additional information.If additional information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).Additional information received on 10 august 2023 states that "pt already diagnosed with ivs rupture before due to stemi.Previously it was planned to refer another hospital for surgery with iabp support for stabilizing patient.Since there was a problem with the balloon, the patient was transferred without iabp support anyway".Returned for investigation was a 40cc 8.0fr fos intra-aortic balloon catheter (iabc) with the original packaging box that matches the serial number on the returned sample.The sample was returned in a cardboard box and was loosely packed within the original packaging carton.Returned with the sample were original packaging trays with some supplied components including: one 0.025in guidewire, pre-dilator, non-teleflex pre-dilator, 8fr teflon sheath/dilator assembly, 8fr dilator, non-teleflex spring-wire guide, short ap tubing, long ap tubing, 40cc inflation driveline tubing, scalpel, 60cc syringe, 8fr teflon sheath w/sidearm and peel-away sheath; both packaging trays and all components were inspected, and no abnormalities were noted.Upon return, the one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.The iabc central lumen was noted broken within the flex-tip assembly area at approximately 5.4cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the bladder.No obvious blood was noted within the helium pathway.No sheath was returned on the iabc.The fos connector and cal key were examined.The fos gray connector was properly seated in the blue clamshell housing and both retaining tabs were intact.The center post of the fos was centered.The blue clamshell housing was examined, and no abnormalities were noted.The cal key was intact.No damage was noted to the cal key.The customer videos were reviewed.The first video shows the iabc bladder under fluoroscopy and the bladder was not fully inflating during pumping.The second video shows the iabc bladder not fully inflating/wou ld not fully unwrap outside of the patient.Both videos are consistent with the reported complaint.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.The cal key and fos were connected to the iabp.The cal key was recognized.The cal key was disconnected and re-connected again after rotating the cal key 180 degrees; the cal key was recognized again.The pump status displayed "ll" low light and "pl" pressure limit, indicating a possible broken fiber.The fos fiber was found broken approximately 27.0cm from the iabc distal tip.No other fiber breaks were noted.An attempt to aspirate and flush the iabc central lumen using a 60cc labinventory 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 broken central lumen.The iabc was leak tested and 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 broken central lumen.The iabc was leak tested again with the iabc distal tip and iabc 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 broken central lumen.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 broken central lumen.Some blood 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 that the "did not inflate completely" is confirmed.During the investigation, the intraaortic balloon catheter (iabc) central lumen was noted broken in the flex-tip assembly area near the iabc distal tip.The damaged central lumen can result in blood entering the helium pathway and an inability of the bladder to fully inflate.The 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 probable root cause of the complaint is undetermined.A non-conformance has been initiated to further investigate the issue.
Event or Problem Description
It was reported that after the iab was inserted and pumping was started, the pump alarmed for "high pressure".The patient was imaged under fluoroscopy, the balloon did not inflate completely.Troubleshooting was attempted however it was determined to remove the iab.After the iab was removed, it was seen that balloon was "faulty".Another attempt was not made as "no spare iac due to constraint.The patient was referred to a bigger center for ivs rupture surgery".No patient harm or injury.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17483648
• Report Number: 3010532612-2023-00418
• Device Sequence Number: 8942132
• Product Code: DSP
• UDI-Device Identifier: 10801902167733
• UDI-Public: 10801902167733
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K021462
• 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): 07/20/2023

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: 07/31/2024
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F22H0035
• 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: 07/20/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• 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