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

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.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: INTRA- 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 Key: 5732075
• MDR Text Key: 47598706
• Report Number: 1219856-2016-00132
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F16B0005
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2016
• 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
• Patient Age: 70 YR