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 Device Displays Incorrect Message (2591)

Patient Problem Insufficiency, Valvular (1926)

Event Date 04/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Returned for evaluation was a 40cc 8.0fr fos iab.The sample was returned with the supplied return kit.The sample was returned in a sealed biohazard bag.Upon return, a 40cc inflation driveline tubing was connected to the short driveline tubing.Spots of blood were noted on the interior of the 40cc inflation driveline tubing.A pressure line was connected to the iab luer.The distal end of the teflon sheath was approximately 47.4cm from the iab distal tip.The teflon sheath was connected to the iab hemostasis cuff which was connected to the cathgard.Blood was observed on the exterior of the sheath, bifurcate, outer lumen and on the interior of the bladder and outer lumen.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.The fos connector and cal key were examined.The fos connector was properly seated in the housing and both retaining tabs were intact.The center post of the fos was centered.The blue slide housing was examined and no abnormalities were noted.The cal key was intact.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.See other remarks section.Other remarks: the cal key and fos were connected to the iabp.The cal key was recognized.The pump status displayed "ll" low light and "pl" pressure limit, indicating a possible broken fiber.The fiber was found broken approximately 1.2cm from iab distal tip.The full length of the fiber was confirmed present with no other notable breaks.The iab was submerged in water and leak tested.A leak was immediately noticeable from the bladder membrane.Under microscopic inspection, a puncture consistent with damage from the broken fiber was noted approximately 1.2cm 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.The catheter was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were 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 unable to get fos signal is confirmed.The fos fiber was broken and therefore the light path could not be established between the sensor and the pump.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 hot line call.The registered nurse (rn) from the cardiac care unit (ccu) told the clinical support specialist (css) that the fos icon is black (fiberoptix iab not connected) and the codes are ll (low light return), re (ratiometric error), pl (fos is measuring outside of pressure range), eo (excessive offset: zeroing procedure resulted in a large difference from factory set calibration).The css had the register nurse disconnect and attempt a reconnect.There was no change.The css then had the register nurse remove the fos and visualize the tip and it is not recessed and is sitting above the housing.The css relayed that for some reason, there is a break in the light returning to the pump and the iab would need to be used by accessing the transduced central lumen.The rn confirmed that this is what she is currently doing.Per the rn the pump is in operator mode as she feels she can get a bit more support timing it herself.The register nurse then had one possible helium loss alarm while the css was on the phone with her.The register nurse checked the tubing and noted no blood.This is the first helium loss alarm.The css asked that the iab be saved for return for testing and the rn is going to mark it with request to save as the patient will be going to another unit after surgery in the am.Additional information on (b)(6) 2016.Length of time in use prior to event: 11-april-2016 2230est in (b)(6) lab list specific iabp alarms that occurred: fos weak, unavailable, connect cal key.

• 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: 5836436
• MDR Text Key: 50920179
• Report Number: 1219856-2016-00179
• 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
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2016
• 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: 18F15D0034
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2015
• 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