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 Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Sample not returned.

Event Description

It was reported via a hotline call from the registered nurse (rn) in the cardiac icu regarding the volume is reading 35cc on a 40cc intra-aortic balloon (iab) and she cannot change it as it is showing 100%.The rn stated she had discussed this issue with sales rep earlier and reviewed occlusive (balloon pressure waveform (bpw) plateau and augmentation were within 25 pts at 35cc fill volume and that the sales rep.Suggested the rn call the hotline to troubleshoot the 100% reading at 35cc.The (css) clinical support specialist had the rn turn the pump off (red off button), disconnect the helium driveline, reconnect and then check the balloon volume and it now read 40cc 100%.The css then had the rn turn the pump back on.Iabp therapy was held for less than 20 seconds.The rn then measured the bpw plateau and augmentation and the plateau was 35 above augmentation.The css asked if the pressures on the iab were correlating to the patient's status and she said not at all.The css asked if it was a fiberoptix iab, which the rn confirmed it was (iab-05840-lws).The rn relayed that it had not been zeroed prior to insertion (icon is blue - fiberoptix iab not zero'd prior to insertion).The css then had the rn do a map calibration and once that was complete, the pressures on the iab were accurate for the patient status and the bpw plateau and augmentation were then only a few points apart.The rn had stated that the md had wanted to pump at 35 cc stating "that the pump will adjust automatically." the css explained that the delivery volume is changed by manual changes only and the pump will not make changes itself.The css suggested that the rn discuss with the md and determine if he wants to pump at 40cc or 35cc knowing now that the pressures are accurate to use to troubleshoot.The css did ask that the pump be sent to biomed for testing to ensure no issues once removed from the patient and that the iab be held for return after removal.The css gave the rn her direct cell number should she have any further issues or if the md had any questions for the css.The rn verbalized understanding of all and has no further questions at this time.Length of time prior to the event: < 24 hours.The patient is stable.

Manufacturer Narrative

Qn#(b)(4).Returned for evaluation was a 40cc 8.0fr iab fos with its supplied returned kit.A stopcock was returned connected to the bifurcate.Blood was noted on the bladder membrane but not within.Small specks of blood were noted on various parts of the catheter.The one-way valve was returned connected to the short driveline tubing.The distal end of the teflon sheath was located approximately 47.5cm from the distal tip of the catheter.No other damage, kinks, or abnormalities were noted to the device.The fos connector and cal key were examined.The gray fos connector was properly seated in the housing and both retaining tabs were intact.The center post of the fos was centered.The blue clamshell housing was examined and no damage was 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 and the fos were recognized.The fos displayed an "ok" status.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.The augmentation pressures measured through the fos properly matched the pressure readings noted on the pressure gauge.A lab inventory guidewire was front loaded through the luer end of the iab.Small amounts of resistance were noted approximately 9.5cm from the luer end of the catheter.The guidewire was able to advance.The guidewire was back loaded through the iab distal tip.Resistance was noted at the same location measured previously.The guidewire was able to advance.No blood or debris exited with the guidewire.A small bend was found at the bifurcate approximately 10cm from the luer end which likely caused the minor resistance.Conclusion: the reported complaint of augmentation difficulty is not confirmed.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 cardiac icu regarding the volume is reading 35cc on a 40cc intra-aortic balloon (iab) and she cannot change it as it is showing 100%.The rn stated she had discussed this issue with sales rep earlier and reviewed occlusive (balloon pressure waveform (bpw) plateau and augmentation were within 25 pts at 35cc fill volume and that the sales rep.Suggested the rn call the hotline to troubleshoot the 100% reading at 35cc.The (css) clinical support specialist had the rn turn the pump off (red off button), disconnect the helium driveline, reconnect and then check the balloon volume and it now read 40cc 100%.The css then had the rn turn the pump back on.Iabp therapy was held for less than 20 seconds.The rn then measured the bpw plateau and augmentation and the plateau was 35 above augmentation.The css asked if the pressures on the iab were correlating to the patient's status and she said not at all.The css asked if it was a fiberoptix iab, which the rn confirmed it was (iab-05840-lws).The rn relayed that it had not been zeroed prior to insertion (icon is blue - fiberoptix iab not zero'd prior to insertion).The css then had the rn do a map calibration and once that was complete, the pressures on the iab were accurate for the patient status and the bpw plateau and augmentation were then only a few points apart.The rn had stated that the md had wanted to pump at 35 cc stating "that the pump will adjust automatically." the css explained that the delivery volume is changed by manual changes only and the pump will not make changes itself.The css suggested that the rn discuss with the md and determine if he wants to pump at 40cc or 35cc knowing now that the pressures are accurate to use to troubleshoot.The css did ask that the pump be sent to biomed for testing to ensure no issues once removed from the patient and that the iab be held for return after removal.The css gave the rn her direct cell number should she have any further issues or if the md had any questions for the css.The rn verbalized understanding of all and has no further questions at this time.Length of time prior to the event: < 24 hours.The patient is stable.

• 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: 5847822
• MDR Text Key: 51230272
• Report Number: 1219856-2016-00177
• 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: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F15M0028
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2015
• 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