MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC; INTRA- AORTIC BALLOON FIBER OPTIC

Catalog Number IAB-05830-LWS

Device Problems Occlusion Within Device (1423); Unable to Obtain Readings (1516)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The sample is not returning.

Event Description

It was reported via a hot line call.The registered nurse (rn) in the cardiac intensive care unit (cicu) is calling to assist with timing assessment.According to the rn, the pump (s/n (b)(4)) has not alarmed and there has been no interruption in therapy.The rn feels the deflation is running late.And the heart rate (hr) on the pump is almost double the actual patients hr.The patient admitted "decently stabilized", pattern trigger.The clinical support specialist (css) discussed improving the ecg leads, and pressure trigger attempted, the arterial pressure (ap) source was noted to be monitor.The fiber optic ap source is not working, central lumen very dampened, currently using the femoral side port slaved in from monitor.Troubleshooting attempted on fiber optic sensor (fos), icon is black (fiber-optix intra-aortic balloon (iab) not connected), slide and calibration key reconnected, click heard, however there were no audible tones.After inquiring, the cath lab reported that the fos did not connect initially while still in the tray.No audible tones.Central lumen troubleshooting did not improve waveform.At this point, the css asked the rn to switch to face time.The css had the rn change the ap source and connect her arterial line directly to the pump.This immediately improved the waveform and hr is now accurate.The css discussed the issues associated with slaving.Better leads on the ecg allowed the rn to use pattern trigger.The medical doctor (md) was present during face time call.Timing also improved although occasionally late deflation noted.The css discussed assessment of the assisted systolic beat which revealed deflation timing is not compromising the heart.The css discussed that with no ischemia present, this may actually assist with better unloading and sv (stroke volume).The doctor agreed with the assessment.

Manufacturer Narrative

Qn#(b)(4).Teleflex did not receive the device for evaluation therefore the reported complaint of "central lumen very dampened" is not able to be confirmed.The root cause of the complaint is undetermined.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 will be monitored for any developing trends.

Event Description

It was reported via a hot line call.The registered nurse (rn) in the cardiac intensive care unit (cicu) is calling to assist with timing assessment.According to the rn, the pump (s/n (b)(4)) has not alarmed and there has been no interruption in therapy.The rn feels the deflation is running late.And the heart rate (hr) on the pump is almost double the actual patients hr.The patient admitted "decently stabilized", pattern trigger.The clinical support specialist (css) discussed improving the ecg leads, and pressure trigger attempted, the arterial pressure (ap) source was noted to be monitor.The fiber optic ap source is not working, central lumen very dampened, currently using the femoral side port slaved in from monitor.Troubleshooting attempted on fiber optic sensor (fos), icon is black (fiber-optix intra-aortic balloon (iab) not connected), slide and calibration key reconnected, click heard, however there were no audible tones.After inquiring, the cath lab reported that the fos did not connect initially while still in the tray.No audible tones.Central lumen troubleshooting did not improve waveform.At this point, the css asked the rn to switch to face time.The css had the rn change the ap source and connect her arterial line directly to the pump.This immediately improved the waveform and hr is now accurate.The css discussed the issues associated with slaving.Better leads on the ecg allowed the rn to use pattern trigger.The medical doctor (md) was present during face time call.Timing also improved although occasionally late deflation noted.The css discussed assessment of the assisted systolic beat which revealed deflation timing is not compromising the heart.The css discussed that with no ischemia present, this may actually assist with better unloading and sv (stroke volume).The doctor agreed with the assessment.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 30CC
• Type of Device: INTRA- AORTIC BALLOON FIBER OPTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; chelmsford MA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 6401342
• MDR Text Key: 69849671
• Report Number: 1219856-2017-00046
• 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: 02/16/2017

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-05830-LWS
• Device Lot Number: 18F16F0003
• Other Device ID Number: 00801902034724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2017
• Initial Date FDA Received: 03/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• 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
• Treatment: LEVOPHED
• Patient Age: 31 YR