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

Catalog Number IAB-S840C

Device Problems Inflation Problem (1310); Kinked (1339); Device Displays Incorrect Message (2591)

Patient Problems No Consequences Or Impact To Patient (2199); Ischemic Heart Disease (2493)

Event Date 08/30/2016

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported via a hotline call from the registered nurse (rn) in the cath lab.The iab was placed while the patient was in the cath lab.The patient is (b)(6).The iab was inserted via the patient's femoral artery without incident.They initiated pumping, and initially the pump started up and ran as expected.Five to ten minutes after start-up the pump began to alarm for high pressure.They had not been able to get the pump to run for longer than 1 or 2 minutes since then, and now it immediately alarmed every time they press on.The clinical support specialist (css) first verified that the alarms have all been high pressure alarms, no helium loss alarms, and no blood in the gas tubing.The css then had a discussion about the typical causes for high pressure alarms.The rn states that the insertion did not seem tortuous at all.There are no kinks in the gas tubing that they have been able to find.The patient is already off of the cath lab table and on the bed.The rn stated that the last shot of fluoro that they did showed that the balloon appeared to be in the right place.The css and rn discussed the possibility that the balloon could have migrated, and they should verify placement again.In the meantime the css also discussed possible kinking just inside the leg at the groin, and they had already tried to hyper-extend the hip with no change.The css had them try a different pump (160334w), but it also immediately alarmed for high pressure.They are going to move the patient back to the cath lab table at this point to check placement.The css asked the rn if he could call back in a few minutes.At 1410 - the css called back, and spoke again with the rn.The rn stated that the iab did appear to be in the correct place, but they have still not been able to get the pump to run.They then removed the iab without incident, and they do not plan on placing another.The patient remains stable at this time without the iabp.

Manufacturer Narrative

(b)(4).Evaluation: the bladder membrane was wrapped in yellow padding.Blood was noted on the bladder membrane but not within.Dried blood was noted on the bifurcate.The distal end of the teflon sheath was located approximately 20cm from the distal tip of the catheter.No kinks, damage, or abnormalities were noted with the device.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 iab was submerged in water and leak tested.No holes or leaks were detected.The unit passed leak test.The iab was pump tested at 100mmhg for 10 minutes and no issues were noted.No high pressure alarms occurred.A lab inventory guidewire was front loaded through the luer end of the iab.Resistance was noted approximately 2.0cm from the luer end of the catheter.The guidewire was not able to advance.Some blood exited with the guidewire.The guidewire was back loaded through the iab distal tip.Resistance was noted approximately 43.5cm from the distal tip.The guidewire was able to advance slowly, but it was not able to advance past 66.0cm from the distal tip.Some blood exited with the guidewire.The central lumen was clotted with blood which likely caused the resistance.No kinks were able to be found on the device.A device history record (dhr) review was not performed.There was no confirmed product failure with the returned sample.Conclusion: the reported complaint of high pressure alarms is not confirmed.The reported complaint was not able to be duplicated during functional testing.The iab passed functional testing.The root cause of the complaint is undetermined.

Event Description

It was reported via a hotline call from the registered nurse (rn) in the cath lab.The iab was placed while the patient was in the cath lab.The patient is 5'9".The iab was inserted via the patient's femoral artery without incident.They initiated pumping, and initially the pump started up and ran as expected.Five to ten minutes after start-up the pump began to alarm for high pressure.They had not been able to get the pump to run for longer than 1 or 2 minutes since then, and now it immediately alarmed every time they press on.The clinical support specialist (css) first verified that the alarms have all been high pressure alarms, no helium loss alarms, and no blood in the gas tubing.The css then had a discussion about the typical causes for high pressure alarms.The rn states that the insertion did not seem tortuous at all.There are no kinks in the gas tubing that they have been able to find.The patient is already off of the cath lab table and on the bed.The rn stated that the last shot of fluoro that they did showed that the balloon appeared to be in the right place.The css and rn discussed the possibility that the balloon could have migrated, and they should verify placement again.In the meantime the css also discussed possible kinking just inside the leg at the groin, and they had already tried to hyper-extend the hip with no change.The css had them try a different pump (b)(4), but it also immediately alarmed for high pressure.They are going to move the patient back to the cath lab table at this point to check placement.The css asked the rn if he could call back in a few minutes.At 1410 - the css called back, and spoke again with the rn.The rn stated that the iab did appear to be in the correct place, but they have still not been able to get the pump to run.They then removed the iab without incident, and they do not plan on placing another.The patient remains stable at this time without the iabp.

• Brand Name: REDIGUARD 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: 5978435
• MDR Text Key: 55691646
• Report Number: 1219856-2016-00223
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F15K0005
• Other Device ID Number: 00801902002679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Weight: 119