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

Catalog Number IAB-05840-LWS

Device Problems Entrapment of Device (1212); Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Thrombus (2101); Loss Of Pulse (2562)

Event Date 06/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2019 @652 a.M.Est, teleflex received a call via the teleflex 24 hour customer hotline.It was reported by the rn from (b)(6) health (b)(6) hospital that a teleflex intra-aortic balloon pump (iabp) alarmed for drain failure.The rn stated that there is some condensation noted in the driveline tubing but "not much".The clinical support specialist (css) asked if there was blood in the condensation trap, the rn reported no.The rn stated that the patient was not running a fever, hr 99-110.The css instructed the rn to empty a small amount of condensation from the condensation trap and the css walked the rn through the steps on how to perform a manual purge.The css explained that the pump will only lose data if powered off, not pump off.The css asked the rn how often this alarm occurred.The rn stated the alarm occurred 3 times since the patient's arrival to the unit 6-7 hours.The rn reported no additional issues at this time.The teleflex css provided her direct phone number to address any additional questions.@1152 a.M.Est a direct call was made from the day shift rn to the css, who explained that the night shift rn had given her the css direct phone number.The rn stated that the iabp alarmed for "helium loss alarm" and the pump stopped pumping.The css explained that these are two different issues and that the pump is always going to stop pumping and go to the off position with a gas alarm for safety.The css asked if there were any kinks noted and the rn stated no kinks in the tubing, no patient movement and no patient ectopy.The rn reported a "small amount of condensation near the adapter at the pump".The css asked if there was any blood and the rn reported "yes".The css asked the rn how long there had been blood in the tubing and the rn stated that blood was noted since the patient arrived into the unit.The rn stated that the blood is near the insertion site.The css explained that any blood noted in the tubing means a hole in the intra-aortic balloon (iab) and the iab must be removed as soon as possible.The css asked the rn again if there was a lot of condensation or blood in the tubing and she reported no.The css explained that even if there wasn't constant alarms or a lot of blood, a hole or abrasion in the iab can clot over and stop the gas alarms intermittently.The css explained that there could be a clot in the iab and there is no way to determine how large the clot is.The amount of blood in the tubing is not an accurate indication of how much is in the iab itself.The css explained that this can cause the catheter to become entrapped, resulting in the possible need for surgical removal.The css also explained that if the iab is dormant in the aorta, that there can also be clot formation on the outside of the iab.The rn stated that the patient was not showing any signs of complications.The rn stated she would call the doctor.@12:00 p.M.Est.The css received a direct call from the rn.The rn wanted to verify if she should not resume pumping.The css said no, the recommendation is to stop pumping to avoid helium embolism.@1:50 p.M.Est.The css called the unit to check on the patient progress.The rn reported that the md was present in the unit to remove the iab.The rn explained that they were unable to remove the iab at the bedside and took the patient to the cath lab for removal, the rn stated that they were still unable to remove the iab in the cath lab and are now taking the patient to surgery.@3:27 p.M.Est.The css received a call from the cardiovascular intensive care unit (cvicu) team lead/rn.The rn reported that they were unable to get the iab out through a cut down.The rn explained that they are currently taking the patient to cardiothoracic (ct) unit.The css discussed the urgency of getting the iab out as soon as possible.The rn reported that the patient has lost pulses to the leg.On (b)(6) 2019 @12:53 p.M.The css spoke to the rn and the rn stated that the patient went in for a surgical cut down, which was attempted 3 inches above the insertion site.They were able to advance but not remove the catheter.There were no pulses to the leg, however minimal perfusion was noted on the cardiothoracic angiogram (cta) which also determined that the catheter was entrapped above the renal arteries.The patient was left open and transferred by air to an outside hospital.

Event Description

On (b)(6), 2019 @652 a.M.Est, teleflex received a call via the teleflex 24 hour customer hotline.It was reported by the rn from texas health huguley hospital that a teleflex intra-aortic balloon pump (iabp) alarmed for drain failure.The rn stated that there is some condensation noted in the driveline tubing but "not much".The clinical support specialist (css) asked if there was blood in the condensation trap, the rn reported no.The rn stated that the patient was not running a fever, hr 99-110.The css instructed the rn to empty a small amount of condensation from the condensation trap and the css walked the rn through the steps on how to perform a manual purge.The css explained that the pump will only lose data if powered off, not pump off.The css asked the rn how often this alarm occurred.The rn stated the alarm occurred 3 times since the patient's arrival to the unit 6-7 hours.The rn reported no additional issues at this time.The teleflex css provided her direct phone number to address any additional questions.@1152 a.M.Est a direct call was made from the day shift rn to the css, who explained that the night shift rn had given her the css direct phone number.The rn stated that the iabp alarmed for "helium loss alarm" and the pump stopped pumping.The css explained that these are two different issues and that the pump is always going to stop pumping and go to the off position with a gas alarm for safety.The css asked if there were any kinks noted and the rn stated no kinks in the tubing, no patient movement and no patient ectopy.The rn reported a "small amount of condensation near the adapter at the pump".The css asked if there was any blood and the rn reported "yes".The css asked the rn how long there had been blood in the tubing and the rn stated that blood was noted since the patient arrived into the unit.The rn stated that the blood is near the insertion site.The css explained that any blood noted in the tubing means a hole in the intra-aortic balloon (iab) and the iab must be removed as soon as possible.The css asked the rn again if there was a lot of condensation or blood in the tubing and she reported no.The css explained that even if there wasn't constant alarms or a lot of blood, a hole or abrasion in the iab can clot over and stop the gas alarms intermittently.The css explained that there could be a clot in the iab and there is no way to determine how large the clot is.The amount of blood in the tubing is not an accurate indication of how much is in the iab itself.The css explained that this can cause the catheter to become entrapped, resulting in the possible need for surgical removal.The css also explained that if the iab is dormant in the aorta, that there can also be clot formation on the outside of the iab.The rn stated that the patient was not showing any signs of complications.The rn stated she would call the doctor.@12:00 p.M.Est.The css received a direct call from the rn.The rn wanted to verify if she should not resume pumping.The css said no, the recommendation is to stop pumping to avoid helium embolism.@1:50 p.M.Est.The css called the unit to check on the patient progress.The rn reported that the md was present in the unit to remove the iab.The rn explained that they were unable to remove the iab at the bedside and took the patient to the cath lab for removal, the rn stated that they were still unable to remove the iab in the cath lab and are now taking the patient to surgery.@3:27 p.M.Est.The css received a call from the cardiovascular intensive care unit (cvicu) team lead/rn.The rn reported that they were unable to get the iab out through a cut down.The rn explained that they are currently taking the patient to cardiothoracic (ct) unit.The css discussed the urgency of getting the iab out as soon as possible.The rn reported that the patient has lost pulses to the leg.On june 8, 2019 @12:53 p.M.The css spoke to the rn and the rn stated that the patient went in for a surgical cut down, which was attempted 3 inches above the insertion site.They were able to advance but not remove the catheter.There were no pulses to the leg, however minimal perfusion was noted on the cardiothoracic angiogram (cta) which also determined that the catheter was entrapped above the renal arteries.The patient was left open and transferred by air to an outside hospital.

Manufacturer Narrative

(b)(4).The teleflex clinical support specialist asked the rn at the hospital how long there had been blood in the tubing.The rn stated that blood had been noted since the patient arrived into the unit and the md was at the bedside.Teleflex received a notification that the device would not be sent back to be investigated.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.In accordance with the teleflex instructions for use, intra-aortic balloon membrane perforation may occur during iabp therapy.The occurrence and severity of iab perforation is unpredictable and may be due to patient physiology, accidental contact with a sharp instrument or by contact with calcified plaque resulting in membrane surface abrasion and eventual perforation.Large perforations are rare.Small perforations can result in asymptomatic release of gas.Perforation can cause blood to appear in the balloon catheter and driveline tubing.If you suspect balloon perforation: - immediately stop pumping.Consider tapering or discontinuing anticoagulation therapy.-remove iab from patient, using recommended removal technique.- leg ischemia can occur either during or after iabp therapy.It can be caused by thrombus formation, an intimal flap or layer separation.Persistent leg ischemia following balloon removal may require vascular surgical correction.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint will be monitored for any developing trends.Other remarks: other device code: 2986.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8752981
• MDR Text Key: 149788126
• Report Number: 3010532612-2019-00200
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F19A0016
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR