MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC; INTRA-AORTIC BALLOON PRODUCT

Catalog Number IAB-05830-LWS

Device Problems Partial Blockage (1065); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).Sample will not be returned for evaluation.

Event Description

It was reported on (b)6) 2015 that the rt (respiratory therapist) was calling the hot line because they had several helium loss alarms.When the clinical support specialist (css) spoke to the rt, he stated that they had a male patient (pt) with a 30 cc fiberoptix sensor (fos) iab inserted via the left femoral artery.The iab had been in since (b)(6) 2015.The pt was in sinus rhythm with frequent pvc's (premature ventricular contraction).They had several helium loss alarms.They checked for kinking and did not note any blood in the tubing.The pt had not been moving and they had not repositioned him.The css asked the rt to fax strips.The alarm strips showed helium loss 2 alarms.There was no visible kink to the catheter on the strip.There were two strips that showed that the baseline was slow to return to zero after an ectopic beat.The css asked if there were any signs of blood in the tubing.On closer inspection, the rn noticed small, "dried" flakes in the tubing near the balloon connector near the pump.The css explained that they may have a small hole in the balloon.The css explained that there should not be any signs of blood in the tubing.They have not had any alarms for the last 40 minutes.At this time a helium leak test would not work.The css advised that they should consider removing the iab.The css also had the rt check the condensation bottle to see if there was any condensation in the bottle and if there was any color to the fluid.There was only a small amount of condensation and the fluid was clear.The css recommended that they consider removing the balloon.The rt said he would discuss this with the md (cardiologist).The css called back after 30 minutes and the rt said they had talked with the md, and he has elected to leave the iab in since they have not had any further alarms.The md said if they had further alarms he would consider discontinuing the iab.The css reminded them to keep a close eye on the tubing to see if the flakes increase or they see more blood.At 7:40 pm mdt, the css received another hot line call.The md called and wanted to discuss the case.At this point they have not had any more alarms (an hour and a half since the last alarm).The md asked if the alarm could have been related to a kink.The css and md discussed the changes that would occur on the bpw (balloon pressure waveform) if the alarm was due to a kink.The css also discussed that there should not be any signs of blood in the gas driveline tubing and there are flakes of blood in the tubing.The css explained that the pump can detect less than a half a cc of helium loss.The css discussed that if they continued to use the iab, when they remove the iab they may feel greater resistance if there is a clot in the balloon.In that case, the iab may get stuck in the artery and the pt will need to go to the or for removal.The md wanted to discuss the changes to the bpw with kink and a hole and the css sent him examples of the bpw changes with alarms.The md also wanted to discuss the removal procedure.The css also discussed how they could maintain the current site for replacement of the iab if the patient required further support from the pump.The patient remained on pressor support besides the balloon pump and md was reluctant to remove the iab at this time.Another call was received on (b)(6) 2015 concerning the same pt.A different rt was calling because they had more helium loss alarms.When the css spoke to the rt she stated that they had three more helium loss 2 alarms and this time the pt showed perfusion color changes during the alarms.The pt became gray and blanched; pt was slow to recover.There was no increase in blood in the tubing.The pt was not moving and there was no kink to the line.The pt remained in sinus rhythm with frequent pvcs.The pt was on 1:1 assist and the map (mean arterial pressure) varied from 70-80.They notified the md again about the alarms.The md wanted them to continue to reset the pump and keep pumping.They said the md felt that the pt was too unstable to try and replace the balloon.The rt and staff wanted to know if there was anything else they should be doing.The pt remained on neo and levophed which were increased to maintain the pt.The css explained that the recommendation would be to have the balloon removed since there is blood flakes in the tubing, but that the md is the final one to make that decision.The css had spoken with the md earlier about the risks with the balloon.The css advised them to continue to monitor the tubing for any increase in signs of blood and continue to notify the md if the alarms persist.They had three more alarms prior to calling the css and now they have not had any more for the last 40 minutes.The alarms had come about two minutes apart.The rt and the bedside rn understood and thanked the css for her assistance.On (b)(6) 2015 at 8:30am mdt (10:30 est) a technician in the cath lab was calling because they were going to bring the pt to the cath lab to change out the iab and the tech had questions on how to do that.When the css spoke to the tech, he asked if they had to take the sheath out when they removed the balloon.The css explained that the balloon would not wrap up small enough to come through the sheath so they will need to remove the balloon and sheath together.The css and tech talked about how they could use the same site if they put the.025 spring wire guide up the central lumen first and then removed the sheath and balloon; they may need to use a larger sheath for the replacement balloon since the hole in the artery will be larger now.The css also asked the tech to have the balloon saved for return and analysis.An update received on (b)(6) 2015 at 10:05 am mdt (12:05 est) stated that the cardiologist called the css directly to let her know that he had met resistance when trying to remove the iab and could only get it part way out.Part of the balloon was out of the pt and the md could tell that there was blood in the catheter.The md stated that he is now sending the pt to the or to have the iab removed.Additional information received from the sales representative (sr) reported that the pt had been transferred to a sister facility for the iab removal.The sr spoke to a staff member in the or and was told that the balloon had a huge solid clot.They used embolectomy catheters to remove the clot in the groin and lower leg.The pt was doing well since iab removal and the leg looked good today.The iab is in pathology.They do not intend to send it in.An update received from the sr on (b)(6) 2015 indicated that the patient was doing better.

Manufacturer Narrative

(b)(4) corrected data: corrected adverse event outcome and catalog number and udi number.Additional information received on 14oct2015 from the sales representative stated that the clinical support specialist taught a clas s last week and was told the patient passed away.The intra-aortic balloon pump is still sequestered with risk management.Evaluation: no product was returned for evaluation.A device history record 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 blood in the helium pathway is not able to be confirmed.The root cause of the complaint is undetermined.

Event Description

It was reported on (b)(6) 2015 that the rt (respiratory therapist) was calling the hot line because they had several helium loss alarms.When the clinical support specialist (css) spoke to the rt, he stated that they had a male patient (pt) with a 30 cc fiberoptix sensor (fos) iab inserted via the left femoral artery.The iab had been in since (b)(6) 2015.The pt was in sinus rhythm with frequent pvc's (premature ventricular contraction).They had several helium loss alarms.They checked for kinking and did not note any blood in the tubing.The pt had not been moving and they had not repositioned him.The css asked the rt to fax strips.The alarm strips showed helium loss 2 alarms.There was no visible kink to the catheter on the strip.There were two strips that showed that the baseline was slow to return to zero after an ectopic beat.The css asked if there were any signs of blood in the tubing.On closer inspection, the rn noticed small, "dried" flakes in the tubing near the balloon connector near the pump.The css explained that they may have a small hole in the balloon.The css explained that there should not be any signs of blood in the tubing.They have not had any alarms for the last 40 minutes.At this time a helium leak test would not work.The css advised that they should consider removing the iab.The css also had the rt check the condensation bottle to see if there was any condensation in the bottle and if there was any color to the fluid.There was only a small amount of condensation and the fluid was clear.The css recommended that they consider removing the balloon.The rt said he would discuss this with the md (cardiologist).The css called back after 30 minutes and the rt said they had talked with the md, and he has elected to leave the iab in since they have not had any further alarms.The md said if they had further alarms he would consider discontinuing the iab.The css reminded them to keep a close eye on the tubing to see if the flakes increase or they see more blood.At 7:40 pm mdt, the css received another hot line call.The md called and wanted to discuss the case.At this point they have not had any more alarms (an hour and a half since the last alarm).The md asked if the alarm could have been related to a kink.The css and md discussed the changes that would occur on the bpw (balloon pressure waveform) if the alarm was due to a kink.The css also discussed that there should not be any signs of blood in the gas driveline tubing and there are flakes of blood in the tubing.The css explained that the pump can detect less than a half a cc of helium loss.The css discussed that if they continued to use the iab, when they remove the iab they may feel greater resistance if there is a clot in the balloon.In that case, the iab may get stuck in the artery and the pt will need to go to the or for removal.The md wanted to discuss the changes to the bpw with kink and a hole and the css sent him examples of the bpw changes with alarms.The md also wanted to discuss the removal procedure.The css also discussed how they could maintain the current site for replacement of the iab if the patient required further support from the pump.The patient remained on pressor support besides the balloon pump and md was reluctant to remove the iab at this time.Another call was received on (b)(6) 2015 concerning the same pt.A different rt was calling because they had more helium loss alarms.When the css spoke to the rt she stated that they had three more helium loss 2 alarms and this time the pt showed perfusion color changes during the alarms.The pt became gray and blanched; pt was slow to recover.There was no increase in blood in the tubing.The pt was not moving and there was no kink to the line.The pt remained in sinus rhythm with frequent pvcs.The pt was on 1:1 assist and the map (mean arterial pressure) varied from 70-80.They notified the md again about the alarms.The md wanted them to continue to reset the pump and keep pumping.They said the md felt that the pt was too unstable to try and replace the balloon.The rt and staff wanted to know if there was anything else they should be doing.The pt remained on neo and levophed which were increased to maintain the pt.The css explained that the recommendation would be to have the balloon removed since there is blood flakes in the tubing, but that the md is the final one to make that decision.The css had spoken with the md earlier about the risks with the balloon.The css advised them to continue to monitor the tubing for any increase in signs of blood and continue to notify the md if the alarms persist.They had three more alarms prior to calling the css and now they have not had any more for the last 40 minutes.The alarms had come about two minutes apart.The rt and the bedside rn understood and thanked the css for her assistance.On (b)(6) 2015 at 8:30am mdt (10:30 est) a technician in the cath lab was calling because they were going to bring the pt to the cath lab to change out the iab and the tech had questions on how to do that.When the css spoke to the tech, he asked if they had to take the sheath out when they removed the balloon.The css explained that the balloon would not wrap up small enough to come through the sheath so they will need to remove the balloon and sheath together.The css and tech talked about how they could use the same site if they put the.025 spring wire guide up the central lumen first and then removed the sheath and balloon; they may need to use a larger sheath for the replacement balloon since the hole in the artery will be larger now.The css also asked the tech to have the balloon saved for return and analysis.An update received on (b)(6) 2015 at 10:05 am mdt (12:05 est) stated that the cardiologist called the css directly to let her know that he had met resistance when trying to remove the iab and could only get it part way out.Part of the balloon was out of the pt and the md could tell that there was blood in the catheter.The md stated that he is now sending the pt to the or to have the iab removed.Additional information received from the sales representative (sr) reported that the pt had been transferred to a sister facility for the iab removal.The sr spoke to a staff member in the or and was told that the balloon had a huge solid clot.They used embolectomy catheters to remove the clot in the groin and lower leg.The pt was doing well since iab removal and the leg looked good today.The iab is in pathology.They do not intend to send it in.An update received from the sr on (b)(6) 2015 indicated that the patient was doing better.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 30CC
• Type of Device: INTRA-AORTIC BALLOON PRODUCT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: kathryn myers ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5144204
• MDR Text Key: 28026984
• Report Number: 1219856-2015-00206
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Respiratory Therapist
• Type of Report: Followup
• Report Date: 09/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: N/A
• Other Device ID Number: 00801902034724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Death; Required Intervention