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

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.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: INTRA- 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 Key: 5965449
• MDR Text Key: 55209503
• Report Number: 1219856-2016-00202
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• 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

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-05840-LWS
• Device Lot Number: 18F16F0042
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2016
• Initial Date FDA Received: 09/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2016
• 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