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

Catalog Number IAB-05840-LWS

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via a hotline call.The registered nurse (rn) from the cardiovascular intensive care unit (cvicu) is calling to troubleshoot persistent helium loss alarms.There is no blood noted in the tubing, there are no noted kinks, connections are intact, they changed the helium tank with no improvement.The clinical support specialist (css) explained this was not related to the alarm they are getting the patient is otherwise supported on pump and the pump is achieving the goals of therapy.There have been no other alarms.Patient paced at 90 bpm some ectopy, although does not seem to be tied to when the alarms are occurring.They had a few of the alarms yesterday, but they stopped for about 12 hours now occurring every couple minutes.Pump is in pattern trigger and using the fiber optic arterial pressure source.The patient is non mobile, some adipose tissue at the insertion site noted.In discussion it was revealed that the patient had been put in 1:2 for some time and is now back in 1:1 and that is when the alarm started again.The css requested a strip from the rn.The strip shows noted widening of artifact and slow return to baseline.The css had the rn decrease the volume in the iab to 38, then 35cc and explained the balloon pressure waveform and shuttle speed to the rn.The alarm continued.The css walked the rn through performing a leak test on the catheter.The catheter failed this test.The css explained at length that this could be related to the kink, but that a leak can not be ruled out.We put the pump in 1:2 while the rn called the doctor to discuss.The doctor chose to keep the ratio at 1:2.The css discussed that they could attempt to go back to 40cc, but the doctor chose to stay as is.There were no more alarms on the pump during our conversation.The css stressed the need to monitor the gas line for any flecks or blood and that they should remove the iab if the alarm continues or blood is noted.The rn understood.The css provided them with her direct number to call if they have additional questions and explained that if the doctor does decide to remove it or the alarms start occurring again, the css will need additional information and the catheter will need to be kept for return.At 2053- a follow up call to account, spoke with another rn who is now caring for the patient.There have been no more alarms.The css reviewed the importance of checking for blood in the tubing and asked that they call me if the alarms begin again.The css received no additional calls.Additional information received on 10aug2016 a call was received by another clinical support specialist on her direct line.At 0418 - the rn called the css's cell phone as the alarms had begun to recur at 35cc and 1:2.Per the rn, she tried prior to calling taking the pump to 1:4 and the alarm did occur again just less frequently.The css had the rn take the iab volume down to 32cc and in 1:2 it was still happening.At that volume setting the plateau was 109 and augmentation was 95.Placement via chest x-ray was unchanged from original confirmation at the "level of the aortic knob" and they were waiting on a stat cxr.Urine output has remained the same.The rn continued to check the helium driveline for blood and there was none.The rn relayed the plan was to complete weaning today and remove the iab.As the pump was alarming frequently, the css suggested that the iab be removed now as there could still be a small hole regardless of seeing no blood.The rn is going to call the cardiologist to discuss.The cardiologist arrives on the unit approx.0530 to round.The rn stated that she is going to save the iab for return.The css told the rn that she would call later in the morning to follow up.The rn has no further questions at this time.At 1237 - the css called the unit back and discussed with the clinical coordinator.The iab was discontinued without issue and the patient status is unchanged.

Manufacturer Narrative

Qn#(b)(4).The sample was returned in a clear biohazard bag within the supplied return kit.The 40cc inflation driveline tubing was connected to the iab short driveline tubing.An ap pressure line was connected to the iab luer.Fluid was noted on the interior of the ap pressure tubing.The distal end of the teflon sheath was approximately 25cm from the iab distal tip.The teflon sheath was connected to the iab hemostasis cuff which was connected to the cathgard.Dried blood was noted on the exterior of the sheath, outer lumen and bladder.The bladder was fully unwrapped.The one-way valve was tethered to the short driveline tubing.A bend was noted at approximately 59.4cm and 69.5cm from the iab distal tip.The fos connector and cal key were examined.The fos connector was properly seated in the housing and both retaining tabs were intact.The center post of the fos was centered.The blue slide housing was examined and no abnormalities were noted.The cal key was intact.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.See other remarks section.Other remarks: the cal key and fos were connected to the iabp.The cal key was recognized.The fos was connected and the iabp zeroed the iab.The pump status displayed "ok" indicating the fiber is fully intact.The iab was submerged in water and leak tested.A leak was immediately noticeable from the bifurcate bushing, approximately 9.0cm from the iab luer.Upon microscopic inspection, the leak occurred around the adhesive bonding to the bifurcate bushing.The root cause of how the leak occurred is undetermined.Engineering has been notified of the issue.This issue will be monitored for any developing trends.The catheter was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.A lab inventory 0.025in guidewire was back loaded through the iab distal tip.Resistance was noted at approximately 59.3cm and 70cm from the iab distal tip.The guidewire was able to advance through the central lumen.No blood or debris was noted.The guidewire was front loaded through the iab luer.Resistance was noted at approximately 13cm and 23.5cm from the iab luer.The guidewire was able to advance through the central lumen.No blood or debris was noted a device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Conclusion: the reported complaint of helium loss alarm is confirmed.An external leak is confirmed from the bifurcate bushing location.The root cause of how the leak occurred is undetermined.Engineering has been notified of the issue.This issue will be monitored for any developing trends.

Event Description

It was reported via a hotline call.The registered nurse (rn) from the cardiovascular intensive care unit (cvicu) is calling to troubleshoot persistent helium loss alarms.There is no blood noted in the tubing, there are no noted kinks, connections are intact, they changed the helium tank with no improvement.The clinical support specialist (css) explained this was not related to the alarm they are getting the patient is otherwise supported on pump and the pump is achieving the goals of therapy.There have been no other alarms.Patient paced at 90 bpm some ectopy, although does not seem to be tied to when the alarms are occurring.They had a few of the alarms yesterday, but they stopped for about 12 hours now occurring every couple minutes.Pump is in pattern trigger and using the fiber optic arterial pressure source.The patient is non mobile, some adipose tissue at the insertion site noted.In discussion it was revealed that the patient had been put in 1:2 for some time and is now back in 1:1 and that is when the alarm started again.The css requested a strip from the rn.The strip shows noted widening of artifact and slow return to baseline.The css had the rn decrease the volume in the iab to 38, then 35cc and explained the balloon pressure waveform and shuttle speed to the rn.The alarm continued.The css walked the rn through performing a leak test on the catheter.The catheter failed this test.The css explained at length that this could be related to the kink, but that a leak can not be ruled out.We put the pump in 1:2 while the rn called the doctor to discuss.The doctor chose to keep the ratio at 1:2.The css discussed that they could attempt to go back to 40cc, but the doctor chose to stay as is.There were no more alarms on the pump during our conversation.The css stressed the need to monitor the gas line for any flecks or blood and that they should remove the iab if the alarm continues or blood is noted.The rn understood.The css provided them with her direct number to call if they have additional questions and explained that if the doctor does decide to remove it or the alarms start occurring again, the css will need additional information and the catheter will need to be kept for return.At 2053- a follow up call to account, spoke with another rn who is now caring for the patient.There have been no more alarms.The css reviewed the importance of checking for blood in the tubing and asked that they call me if the alarms begin again.The css received no additional calls.Additional information received on 10aug2016 a call was received by another clinical support specialist on her direct line.At 0418 - the rn called the css's cell phone as the alarms had begun to recur at 35cc and 1:2.Per the rn, she tried prior to calling taking the pump to 1:4 and the alarm did occur again just less frequently.The css had the rn take the iab volume down to 32cc and in 1:2 it was still happening.At that volume setting the plateau was 109 and augmentation was 95.Placement via chest x-ray was unchanged from original confirmation at the "level of the aortic knob" and they were waiting on a stat cxr.Urine output has remained the same.The rn continued to check the helium driveline for blood and there was none.The rn relayed the plan was to complete weaning today and remove the iab.As the pump was alarming frequently, the css suggested that the iab be removed now as there could still be a small hole regardless of seeing no blood.The rn is going to call the cardiologist to discuss.The cardiologist arrives on the unit approx.0530 to round.The rn stated that she is going to save the iab for return.The css told the rn that she would call later in the morning to follow up.The rn has no further questions at this time.At 1237 - the css called the unit back and discussed with the clinical coordinator.The iab was discontinued without issue and the patient status is unchanged.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: INTRA- AORTIC BALLOON FIBER OPTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: anne rosenberger ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 5913901
• MDR Text Key: 53505331
• Report Number: 1219856-2016-00190
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/07/2016

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 Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F16F0021
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2016
• Initial Date FDA Received: 08/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2016
• 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