MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. IAB : 8 FR - 40 CC FOS; INTRA-AORTIC BALLOON FOS

Catalog Number IAB-05840-LWS

Device Problem Gas/Air Leak (2946)

Patient Problems Congestive Heart Failure (1783); Cardiogenic Shock (2262)

Event Date 07/16/2014

Event Type  malfunction  

Event Description

It was reported via a call that the rn in the intensive care unit was receiving frequent he (helium) loss alarms.The intra-aortic balloon (iab) was inserted less than one hour ago and the patient was in the operating room (o.R.) for an aicd (automatic implantable cardioverter defibrillator) removal due to infection and placement of temporary pacer.The iab was placed in the left femoral via a sheath after the original iab that had been in for seven days was removed from the right femoral.Removal of the original iab was solely due to sepsis.The rn stated that she is receiving the alarms every 2 to 3 minutes.The patient is intermittently capturing from aicd with rates in the 70 to 80's.The patient is approximately (b)(6) tall and of normal stature with no significant angle to insertion of iab; intubated, sedated and draped on operating room table.A 40 cc iab was inserted post removal of original iab.There were no issues reported during insertion.When the iab was inserted the rn began pumping and received the first he loss alarm shortly after initiating pumping.The rn then switched to a second pump and continued to receive the alarms and called the hotline.The rn confirmed with the clinical support specialist (css) that there was no visible kinking, no ectopic beats and no blood noted in the driveline.The rn was waiting to discuss this with the physician who was on her way to the operating room the css then asked the rn to assess the balloon pressure waveform (bpw) and augmentation which were approximately 30 points different (123 and 95 respectively).The css had the rn decrease the volume to 37 cc which then produced a bpw plateau pressure of 112.The css and rn discussed how this was now a better fit of the iab in th e aorta.The pump alarmed 3 times during the css and rn's conversation and the rn checked the driveline again and still no blood.The css did state that due to how often the alarm was occurring, it was probably a small hole and the iab should be removed.The css told the rn to stop pumping, clamp the tubing and remove the iab within 30 minutes to avoid thrombus formation.The rn relayed all of this to the md who is not in the operating room.The css told the rn that she would call her back in 2 hours to follow-up after the case.At 1558 (b)(6) the rn called the css back.The case was over and they were preparing to pull the iab.There was still no blood in the driveline, they continued pumping during the case on 1:4 and continued to receive he loss alarms throughout the case.At 1804 (b)(6) the css called the rn to follow up and spoke to another staff member as she was busy at the moment.The patient did have the iab removed and another was not placed.The patient was now in the icu.Outcome of the patient is unchanged throughout the call.

Manufacturer Narrative

(b)(4).After completion of the investigation and review on (b)(4) 2014, the reportability decision was changed from non-reportable event to a reportable event.Device evaluation: returned for evaluation was a 40 cc 8fr iab assembly.Blood was noted on the entire iab.The one-way valve was tethered to the short driveline tubing.Packaging related bend was noted at 33 cm from the iab distal tip.The teflon sheath distal tip was at 44 cm from the iab distal tip.The 6 inch ap (arterial pressure) line was returned attached to the luer end.The 40 cc driveline tubing was returned attached to the one-way valve.The bladder was fully unwrapped.The fos connector and cal key were examined.The center post was properly seated in the housing and both retaining tabs were intact.The center post of the fiberoptix sensor (fos) was centered.The blue slide housing was examined and no abnormalities were noted.There were no scrapes or gouges.The gray connector was not recessed in the blue clam shell housing.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.A lab inventory 0.025 inch spring wire guide (swg) was front loaded through the luer end of the iab.Slight resistance was encountered; the swg ws able to advance.The swg was back loaded through the iab distal tip.Slight resistance was encountered; the swg was able to advance.No blood or debris exited with the swg.The cal key and fos were connected to the iabp.The cal key was recognized.The fos was zeroed and recognized.The iabp status was "ok." the iab was submerged in the water and leak tested.The iab failed.No holes or leaks were detected in the bladder membrane, catheter body, or bifurcate.Bubbles were coming out from the fos connector indicating that there was a leak somewhere in the blue or yellow fiber jacket or within the bifurcate/fos channel.The blue fiber jacket area over the fos strain relief tubing was cross sectioned in a few pieces to find the possible leak point.The sections were microscopically examined and appeared that the tubing id was not properly packed with epoxy.Voids were seen in the epoxy from the bifurcate edge to 2.2 to 2.6 mm along the strain relief tubing.The primary seal of the fos to the drive line entry point within the bifurcate could not be examined (opaque); however a gas path must exist in this area to permit the observed leakage.This is a manufacturing defect, the leak occurred due to inadequate seal of the fos to drive line pathway.Conclusion: the reported complaint of helium loss alarm is confirmed through visual examination and functional testing.There was a leak at the fos to bifurcate junction.This is a manufacturing process defect.(b)(4) has been opened to further investigate this issue to root cause.

• Brand Name: IAB : 8 FR - 40 CC FOS
• Type of Device: INTRA-AORTIC BALLOON FOS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth st.; everett MA 02149
• Manufacturer Contact: kathryn myers, regulatory assoc. ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 4067677
• MDR Text Key: 4738671
• Report Number: 1219856-2014-00140
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/20/2014

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 Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F14E006
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/05/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2014
• Initial Date FDA Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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