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

Model Number	IPN915319
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Reported as "axillary insertion blood flecks noted in gas line".As reported by the clinical support specialist: "[physician] called the hotline for assistance troubleshooting helium loss alarms.Iab inserted yesterday afternoon via axillary insertion after removing a femorally inserted iab, helium loss alarm recently started.I discussed the angle of insertion and decreasing volume to improve gas speed.Additional discussion determined there is blood noted in the gas line.(information not initially provided).I discussed with the [physician] that the iab should be removed as this means an abrasion in the iab.We discussed that the amount of blood is not relevant, and that there could be larger amounts in the iab and result in catheter entrapment.He stated he would discuss with the attending.Follow up calls with rns, iab was not removed.Stated that the md chose to continue pumping and that the blood was from insertion.I explained that this is not blood from insertion, that there is an abrasion of the iab membrane and explained the risks again.The rn reported that they decreased the volume to 38cc and there have been no additional alarms.I explained that the risk remains that the alarms have likely stopped due to the abrasion clotting.The alarms may begin again and more blood may be noted in the line or not but the recommendation is still to stop pumping and remove the iab.Last follow up call- iab still in place, no additional alarms.Patient critical but stable.Rn has my direct number for updates or changes.I requested the iab be kept for return if removed.Pump is pumping in autopilot mode using the fos ap waveform with no noted issues." no patient injury or consequence.Additional information states the first femorally inserted iab was removed so that the patient could ambulate.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
Reported as "axillary insertion blood flecks noted in gas line".As reported by the clinical support specialist: "[physician] called the hotline for assistance troubleshooting helium loss alarms.Iab inserted yesterday afternoon via axillary insertion after removing a femorally inserted iab, helium loss alarm recently started.I discussed the angle of insertion and decreasing volume to improve gas speed.Additional discussion determined there is blood noted in the gas line.(information not initially provided).I discussed with the [physician] that the iab should be removed as this means an abrasion in the iab.We discussed that the amount of blood is not relevant, and that there could be larger amounts in the iab and result in catheter entrapment.He stated he would discuss with the attending.Follow up calls with rns, iab was not removed.Stated that the md chose to continue pumping and that the blood was from insertion.I explained that this is not blood from insertion, that there is an abrasion of the iab membrane and explained the risks again.The rn reported that they decreased the volume to 38cc and there have been no additional alarms.I explained that the risk remains that the alarms have likely stopped due to the abrasion clotting.The alarms may begin again and more blood may be noted in the line or not but the recommendation is still to stop pumping and remove the iab.Last follow up call- iab still in place, no additional alarms.Patient critical but stable.Rn has my direct number for updates or changes.I requested the iab be kept for return if removed.Pump is pumping in autopilot mode using the fos ap waveform with no noted issues." no patient injury or consequence.Additional information states the first femorally inserted iab was removed so that the patient could ambulate.

• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16137139
• Report Number: 3010532612-2023-00019
• Device Sequence Number: 12441835
• Product Code: DSP
• UDI-Device Identifier: 10801902167733
• UDI-Public: 10801902167733
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K021462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2022

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: 09/30/2023
• Device Model Number: IPN915319
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F21K0022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2022
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Male