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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 BALLOOON PRODUCTS

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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC INTRA- AORTIC BALLOOON PRODUCTS Back to Search Results
Catalog Number IAB-05840-LWS
Device Problem No Display/Image (1183)
Patient Problems Aortic Insufficiency (1715); Atherosclerosis (1728); Mitral Insufficiency (1963)
Event Date 05/23/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient undergoing (avr)aortic valve replacement, (mvr) mitral valve replacement & (cags) coronary artery bypass surgery - required counter-pulsation therapy due to cardiogenic shock and to come off bypass in the cardiac theater. The perfusionist from the cardiac theatre phoned the product manager to let him know that they had a fiber optic 40cc catheter zeroed prior to insertion via a sheath (polyurethane with side port) in the right femoral - green bulb and therapy commenced. Green bulb disappeared went black with blue background - and a2w auto pilot, therefore the pump switched automatically to ecg/ap trigger and therapy continued. The md wanted to change the (iabc) intra- aortic balloon catheter so that (fos) fiber-optic sensor can be used. The perfusionist was talked through the correct zero fos and all worked well. The iabc was successfully changed via the same insertion site. There was no death, injuries or complications. There was a delay of 5- 10 minutes while the catheter was replaced.
 
Manufacturer Narrative
(b)(4) returned for evaluation was a 40cc 8. 0fr fos iab with its original packaging. Blood was noted within the bladder membrane and short driveline tubing. The teflon sheath was returned on the bladder membrane. Buckling was noted on the sheath approximately 12. 0cm from the distal end of the sheath. The approximately length of the buckling was 3. 0cm. The buckling is consistent with attempting to remove the catheter through the sheath. The one-way valve was returned connected to the inflation lumen. The ifu states: "do not remove arrow iab through hemostasis sheath introducer or hemostasis device. Once unwrapped (unfurled), balloon profile will not allow passage through the sheath and attempted removal in this manner may result in arterial tearing, dissection or balloon damage. " the fos connector and cal key were examined. The gray fos connecter was recessed within its housing and both retaining tabs were intact. The center post of the fos was centered. The blue clamshell housing was examined and no abnormalities were noted. The cal key was intact. The bladder thickness was measured at six points with measurements ranging from 0. 0053in-0. 0059in and was within specification. See other remarks section. Other remarks: 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. The cal key and fos were connected to the iabp. The cal key was recognized. The pump status was "ll pl" indicating a potential broken fiber. After removing the sheath from the catheter, the flex tip assembly was found unraveled and broken. The break to the central lumen occurred 8. 5cm from the distal tip of the catheter and was found puncturing the bladder membrane. The damage to the central lumen is consistent with the removal difficulty potentially occurring from attempting to remove the catheter through the sheath. The fiber was found broken at the location of the broken central flex tip assembly. The iab was not able to be leak tested because of the damaged state of the device upon return. 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 was returned with a recessed fos connector; therefore, a light path could not be established between the sensor and the pump. The root cause of the recessed fos is undetermined.
 
Event Description
It was reported that a patient undergoing (avr)aortic valve replacement, (mvr) mitral valve replacement & (cags) coronary artery bypass surgery - required counter-pulsation therapy due to cardiogenic shock and to come off bypass in the cardiac theater. The perfusionist from the cardiac theatre phoned the product manager to let him know that they had a fiber optic 40cc catheter zeroed prior to insertion via a sheath (polyurethane with side port) in the right femoral - green bulb and therapy commenced. Green bulb disappeared went black with blue background - and a2w auto pilot, therefore the pump switched automatically to ecg/ap trigger and therapy continued. The md wanted to change the (iabc) intra- aortic balloon catheter so that (fos) fiber-optic sensor can be used. The perfusionist was talked through the correct zero fos and all worked well. The iabc was successfully changed via the same insertion site. There was no death, injuries or complications. There was a delay of 5- 10 minutes while the catheter was replaced.
 
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Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 40CC
Type of DeviceINTRA- AORTIC BALLOOON PRODUCTS
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 Key5732075
MDR Text Key47598706
Report Number1219856-2016-00132
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/25/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/17/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2018
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F16B0005
Other Device ID Number00801902007247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/02/2016
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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