• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC INTRA- AORTIC BALLOON FIBER OPTIC Back to Search Results
Catalog Number IAB-05840-LWS
Device Problems Continuous Firing (1123); Loose or Intermittent Connection (1371); Failure to Calibrate (2440)
Patient Problems Non specific EKG/ECG Changes (1817); Venipuncture (2129)
Event Date 05/11/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Teleflex received the device for analysis. The reported complaint is that the balloon started to fire twice for every beat is not able to be confirmed. Double pumping can occur if the ecg pads and electrodes are not correctly attached or become unattached. Double pumping cannot occur due to an iab catheter failure. The root cause of the complaint is undetermined. 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. No further action required. (b)(4).
 
Event Description
It was reported that a patient had a low ejection fraction (ef) and it was decided that we would put in a balloon pre-operatively. The perfusionist handed up a 40cc balloon and plugged it into the console. The console did not recognize the fiber optics and did not calibrate. They tried cleaning the fiber optic sensor with alcohol as he had been directed to do so previously. This did not help. We also had some issue with electrocardiogram (ecg) reading so they decided it would be best to switch the console. Upon changing the console, we found that we were still unable to calibrate the fiber optic sensor but decided to continue with this balloon as we would be able to hook up a transducer and use that instead. This plan worked well, we went on bypass and turned off the balloon for the duration of the pump run. Once we came off, there were some intermittent issues with ecg timing, the ecg pads and clips were checked and all appeared to be as it should. The balloon was put into autopilot mode and was functioning well until just before the patient was moved to the stretcher for transport to the unit. At this time the balloon started firing twice for every beat and was firing on systole. The patient became unstable and the balloon was turned off. The perfusionist attempted to manually select a different trigger, triggering off the skin vs monitor, pressure vs ecg, but nothing seemed to be working. They elected to insert another balloon catheter in the right groin (first one was in the left) and then pull the other one out. To be sure the console wasn't the issue, a 3rd balloon console was used with the new balloon and we immediately got fiber optic calibration but still had issues with the ecg. I was able to time the balloon manually off the pressure and we were able to get upstairs without further complication. I checked in with the nurse the following morning and there were no issues overnight and the balloon was in autopilot mode.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient had a low ejection fraction (ef) and it was decided that we would put in a balloon pre-operatively. The perfusionist handed up a 40cc balloon and plugged it into the console. The console did not recognize the fiber optics and did not calibrate. They tried cleaning the fiber optic sensor with alcohol as he had been directed to do so previously. This did not help. We also had some issue with electrocardiogram (ecg) reading so they decided it would be best to switch the console. Upon changing the console, we found that we were still unable to calibrate the fiber optic sensor but decided to continue with this balloon as we would be able to hook up a transducer and use that instead. This plan worked well, we went on bypass and turned off the balloon for the duration of the pump run. Once we came off, there were some intermittent issues with ecg timing, the ecg pads and clips were checked and all appeared to be as it should. The balloon was put into autopilot mode and was functioning well until just before the pati ent was moved to the stretcher for transport to the unit. At this time the balloon started firing twice for every beat and was firing on systole. The patient became unstable and the balloon was turned off. The perfusionist attempted to manually select a different trigger, triggering off the skin vs monitor, pressure vs ecg, but nothing seemed to be working. They elected to insert another balloon catheter in the right groin (first one was in the left) and then pull the other one out. To be sure the console wasn't the issue, a 3rd balloon console was used with the new balloon and we immediately got fiber optic calibration but still had issues with the ecg. I was able to time the balloon manually off the pressure and we were able to get upstairs without further complication. I checked in with the nurse the following morning and there were no issues overnight and the balloon was in autopilot mode.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 40CC
Type of DeviceINTRA- 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
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key6613009
MDR Text Key108766343
Report Number1219856-2017-00114
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2019
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F17C0025
Other Device ID Number00801902007247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-