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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC INTRA- AORTIC BALLOON FIBER OPTIC Back to Search Results
Catalog Number IAB-05840-LWS
Device Problem Gas Leak (2946)
Patient Problem Ischemic Heart Disease (2493)
Event Date 08/01/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via a hotline call at 1522 from the registered nurse (rn) in the cticu was calling to assist in troubleshooting a patient that just arrived from the cath lab. The rn told the clinical support specialist (css) that they are having persistent helium loss alarms (every 1-2 minutes). This was reported to have started in the cath lab soon after insertion. The iab is inserted in the right femoral artery, there is minimal to no adipose tissue at the insertion sight. The patient is flat and not moving. The pump is currently in 1:2 ratio setting. The patient is in and out of a rapid atrial-fibrillation. The rn feels the pump is augmenting well and supporting the patient when not alarming. The css requested that the rn send a strip that printed with the alarm that just occurred during our conversation. There are no noted kinks and no blood in the gas line tubing. The rn stated during the conversation that they had "also lost the fiber optic a-line source. " the fos was initially zeroed in the cath lab but reported to have soon been lost (flat line, no pressures, black icon) pump is using the xducer. The css told the rn that we would address that secondary to the more urgent helium loss issue. While waiting for the strip, we discussed patient repositioning, hyper extension of the hip etc. , which did not correct the problem. The css had the rn reduce the volume to 38 and then 36cc, the alarm continued. The attached strip does note a squared off waveform and slow return to baseline pressure. The css discussed with the rn and on speaker phone with md that there is potentially a small abrasion or hole in the iab. The css discussed the balloon pressure waveform as well as the volume reduction and reduced ratio not correcting the problem which will usually improve the situation if the issue is a kink. They had already switched pumps prior to calling the hotline. The css walked them through a leak test. The leak test confirmed that the catheter is the cause. The css discussed that even if this were a kink, the catheter is unable to provide optimal care but we also reviewed the potential complications with blood accumulating in the iab and the resulting potential for catheter entrapment. The md agreed that removal would be best. While preparing for removal, the css asked the rn to disconnect and reconnect the fos slide, the click connection was heard but there were no audible tones noted. The css explained that this could likely be related to the kink as the catheter is connecting but no light return is being received. The catheter was removed and the md chose to see if the patient could tolerate not having the pump at this time. There were no complications with removal and the catheter is being kept for return. At 2130 est. - an iab was reinserted into the left femoral artery without difficulty. The pump is pumping well utilizing the fiber optic ap source.
 
Manufacturer Narrative
(b)(4). No product was returned for evaluation. According to the event details, the clinical support specialist (css) had the user perform a leak test, and it was found that the catheter was likely the cause of the helium loss alarms. The device was removed as a result. 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 alarms is confirmed based on the information provided to the css. The product was not returned for evaluation. The root cause of the complaint is undetermined.
 
Event Description
It was reported via a hotline call at 1522 from the registered nurse (rn) in the cticu was calling to assist in troubleshooting a patient that just arrived from the cath lab. The rn told the clinical support specialist (css) that they are having persistent helium loss alarms (every 1-2 minutes). This was reported to have started in the cath lab soon after insertion. The iab is inserted in the right femoral artery, there is minimal to no adipose tissue at the insertion sight. The patient is flat and not moving. The pump is currently in 1:2 ratio setting. The patient is in and out of a rapid atrial-fibrillation. The rn feels the pump is augmenting well and supporting the patient when not alarming. The css requested that the rn send a strip that printed with the alarm that just occurred during our conversation. There are no noted kinks and no blood in the gas line tubing. The rn stated during the conversation that they had "also lost the fiber optic a-line source. " the fos was initially zeroed in the cath lab but reported to have soon been lost (flat line, no pressures, black icon) pump is using the xducer. The css told the rn that we would address that secondary to the more urgent helium loss issue. While waiting for the strip, we discussed patient repositioning, hyper extension of the hip etc. , which did not correct the problem. The css had the rn reduce the volume to 38 and then 36cc, the alarm continued. The attached strip does note a squared off waveform and slow return to baseline pressure. The css discussed with the rn and on speaker phone with md that there is potentially a small abrasion or hole in the iab. The css discussed the balloon pressure waveform as well as the volume reduction and reduced ratio not correcting the problem which will usually improve the situation if the issue is a kink. They had already switched pumps prior to calling the hotline. The css walked them through a leak test. The leak test confirmed that the catheter is the cause. The css discussed that even if this were a kink, the catheter is unable to provide optimal care but we also reviewed the potential complications with blood accumulating in the iab and the resulting potential for catheter entrapment. The md agreed that removal would be best. While preparing for removal, the css asked the rn to disconnect and reconnect the fos slide, the click connection was heard but there were no audible tones noted. The css explained that this could likely be related to the kink as the catheter is connecting but no light return is being received. The catheter was removed and the md chose to see if the patient could tolerate not having the pump at this time. There were no complications with removal and the catheter is being kept for return. At 2130 est. - an iab was reinserted into the left femoral artery without difficulty. The pump is pumping well utilizing the fiber optic ap source.
 
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Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 40CC
Type of DeviceINTRA- 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 Key5884110
MDR Text Key52380824
Report Number1219856-2016-00186
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2018
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F16F0042
Other Device ID Number00801902007247
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/24/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/17/2016 Patient Sequence Number: 1
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