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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 Occlusion Within Device (1423)
Patient Problems No Consequences Or Impact To Patient (2199); Cardiogenic Shock (2262)
Event Date 08/20/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). See 1219856-2016-00201 for other patient event.
 
Event Description
It was reported via a hotline call to the clinical support specialist (css) from the perfusionist. They had an emergent case in the cath lab with a patient, (b)(6). They inserted a second fiberoptix iab. It again was zeroed appropriately and inserted without difficulty. They were able to start pumping without alarms, but they had no arterial pressure waveform. The perfusionist could see the augmentation on the arterial pressure waveform from their other pressure on their monitor in the cath lab. The pump was switching back and forth from fiberoptix and transducer. The perfusionist had no pressure waveform from the central lumen also. They had checked the transducer system and it was ok. They even changed out the pump console for a second console (sn (b)(4)). They still had no arterial pressure waveform. According to the perfusionist they also changed out the transducer set-up and still no pressure waveform from the central lumen. The perfusionist stated that they did see an "fos signal weak" message on the screen. The perfusionist then took the patient to the or for emergent cabg. The surgeon elected to remove the iab post-surgery in the or since the patient's main heart issue was right sided. A third balloon was not inserted. When the clinical support specialist and perfusionist spoke the css stated that the second iab, most likely the fiberoptix was damaged on insertion since they got the "fos signal weak" and no arterial pressure waveform. The css also explained that the central lumen may have clotted off on the second iab. This institution only uses normal saline in their transducer set-ups. The css and perfusionist also discussed that they could have used another arterial line to connect to the pump for the arterial pressure waveform for pumping. The patient is stable post iab removal.
 
Manufacturer Narrative
(b)(4). The sample was returned with the supplied return kit and was in a sealed bio-hazard bag. The fos fiber and short driveline tubing were cut off at the iab bifurcate. The fos connector, cal key and one-way valve were not returned. The distal end of the teflon sheath was approximately 48. 5cm from the iab distal tip. The teflon sheath was connected to the iab hemostasis cuff which was connected to the cathgard. Liquid blood was noted on the interior of the sheath sidearm. Dried blood was noted on the exterior of the sheath, outer lumen and bladder. Dried pink substance was noted on the exterior of the iab bifurcate, cathgard and sheath. The bladder was fully unwrapped. The one-way valve was not returned with the sample; therefore it could not be tested. The fos connection was unable to be tested due to the returned state of the iab. Upon checking the fos fiber, the fiber was found broken approximately 1. 2cm from iab distal tip. The iab was submerged in water and leak tested. No holes or leaks were detected. Full inflation was achieved. The unit passed leak test. 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 iab distal tip. No resistance was noted; 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. No resistance was noted; 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 fos signal lost is confirmed. The fos fiber was broken and therefore the light path could not be established between the sensor and the pump. The fos connector and cal key were not returned; therefore, functional testing of the fos was unable to be performed. The root cause of the broken fiber is undetermined.
 
Event Description
It was reported via a hotline call to the clinical support specialist (css) from the perfusionist. They had an emergent case in the cath lab with a patient, (b)(6). They inserted a second fiberoptix iab. It again was zeroed appropriately and inserted without difficulty. They were able to start pumping without alarms, but they had no arterial pressure waveform. The perfusionist could see the augmentation on the arterial pressure waveform from their other pressure on their monitor in the cath lab. The pump was switching back and forth from fiberoptix and transducer. The perfusionist had no pressure waveform from the central lumen also. They had checked the transducer system and it was ok. They even changed out the pump console for a second console (sn (b)(4)). They still had no arterial pressure waveform. According to the perfusionist they also changed out the transducer set-up and still no pressure waveform from the central lumen. The perfusionist stated that they did see an "fos signal weak" message on the screen. The perfusionist then took the patient to the or for emergent cabg. The surgeon elected to remove the iab post-surgery in the or since the patient's main heart issue was right sided. A third balloon was not inserted. When the clinical support specialist and perfusionist spoke the css stated that the second iab, most likely the fiberoptix was damaged on insertion since they got the "fos signal weak" and no arterial pressure waveform. The css also explained that the central lumen may have clotted off on the second iab. This institution only uses normal saline in their transducer set-ups. The css and perfusionist also discussed that they could have used another arterial line to connect to the pump for the arterial pressure waveform for pumping. The patient is stable post iab removal.
 
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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 Key5965449
MDR Text Key55209503
Report Number1219856-2016-00202
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/22/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2018
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F16F0042
Other Device ID Number00801902007247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/26/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2016
Was Device Evaluated by Manufacturer? Yes
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

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