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

Catalog Number IAB-05840-LWS

Device Problems Backflow (1064); Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via a hotline call.The (rn) registered nurse from the (cvcc) cardiac vascular critical care is calling with a patient that they received from the cath lab that the fos connection did not work at all.They connected the central lumen, and the pump had been using that with no issues in autopilot.The rn stated that there is now a flat line from the xducer (ap) arterial pressure from the central lumen.Her pressures are all reading 14.The rn is calling for help troubleshooting this.The clinical support specialist (css)first verified that the pump has continued to pump through all of this with no delays in therapy.The css then walked the rn her through troubleshooting the central lumen.The css had the rn attempt to flush, and the rn said that it would not flush.The css also had the rn attempt to draw blood back from it, but again the rn said that there was nothing coming back.The rn stated that there is blood visible in the arterial line tubing from the central lumen.The css verified that they are using heparinized saline in the flush bag.The rn then stated that the pressure bag is totally deflated, and she does not know how long it has been that way.The css explained to the rn that is why the central lumen clotted off and that they should cap that line and mark it not to use.The css also explained that they will need to use an alternate ap source.The rn stated that they have both a radial a-line and the side port from the sheath.The css and rn discussed the differences those sources can make for the pump.They directly connected the radial a-line to the balloon pump.They now have a good waveform on the pump, and timing appears to be appropriate.The rn zeroed the a-line, and the pressures are now what they were before, and the pump is supporting the patient well.The rn thanked the css for the help, and stated that she has no further needs.Length of time prior to event: 7 hours.Pump alarms that occurred: no ap signal.

Manufacturer Narrative

(b)(4).The sample was returned in a clear biohazard bag.The fos fiber was cut off at the iab bifurcate.The fos connector and cal key were not returned.The distal end of the teflon sheath was approximately 35.5cm from the iab distal tip.The teflon sheath was connected to the iab hemostasis cuff which was connected to the cathgard.Clear fluid was noted on the interior of the sheath sidearm.An ap pressure line was connected to the iab luer.Liquid blood was noted on the interior of the ap pressure tubing.Dried blood was noted on the exterior of the sheath, outer lumen, one-way valve, bladder and on the interior of the short driveline tubing and bladder.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.The bladder thickness was measured at six points with measurements within specification.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 catheter was aspirated and flushed using a 60cc lab-inventory syringe.Blood was noted upon initial flushing/aspiration.Other remarks: 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 1.4cm from iab distal tip.The iab was submerged in water and leak tested.A leak was immediately noticeable from bladder membrane.Under microscopic inspection, a puncture consistent with damage from the broken fiber was noted approximately 1.7cm from the distal tip of the iab.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.Ifu states: "using current hospital protocol, connect pressure tubing extension to a prepared standard arterial pressure monitoring assembly which delivers 3 cc of pressurized flush per hour." this action is to maintain the patency of the arterial line.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 central lumen occluded is confirmed.Upon aspiration and flushing, blood initially exited the central lumen but the test was successfully completed.The blood built up in the central lumen may have occurred from not maintaining a patency of the arterial line.Also, blood was found on the interior of the iab bladder membrane.A puncture consistent with contact from the broken fiber was found near the distal tip of the iab which likely allowed blood to enter the helium pathway.The root cause of the broken fiber is undetermined.

Event Description

It was reported via a hotline call.The (rn) registered nurse from the (cvcc) cardiac vascular critical care is calling with a patient that they received from the cath lab that the fos connection did not work at all.They connected the central lumen, and the pump had been using that with no issues in autopilot.The rn stated that there is now a flat line from the xducer (ap) arterial pressure from the central lumen.Her pressures are all reading 14.The rn is calling for help troubleshooting this.The clinical support specialist (css) first verified that the pump has continued to pump through all of this with no delays in therapy.The css then walked the rn her through troubleshooting the central lumen.The css had the rn attempt to flush, and the rn said that it would not flush.The css also had the rn attempt to draw blood back from it, but again the rn said that there was nothing coming back.The rn stated that there is blood visible in the arterial line tubing from the central lumen.The css verified that they are using heparinized saline in the flush bag.The rn then stated that the pressure bag is totally deflated, and she does not know how long it has been that way.The css explained to the rn that is why the central lumen clotted off and that they should cap that line and mark it not to use.The css also explained that they will need to use an alternate ap source.The rn stated that they have both a radial a-line and the side port from the sheath.The css and rn discussed the differences those sources can make for the pump.They directly connected the radial a-line to the balloon pump.They now have a good waveform on the pump, and timing appears to be appropriate.The rn zeroed the a-line, and the pressures are now what they were before, and the pump is supporting the patient well.The rn thanked the css for the help, and stated that she has no further needs.Length of time prior to event: 7 hours.Pump alarms that occurred: no ap signal.

• 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: 5846390
• MDR Text Key: 51140886
• Report Number: 1219856-2016-00175
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/13/2016

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: 04/30/2017
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18S15D0034
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2016
• Initial Date FDA Received: 08/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2016
• 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