• 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 Problem Fluid Leak (1250)
Patient Problem Atherosclerosis (1728)
Event Date 05/25/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It has been reported that the event involved a 160cm in height. While in open heart surgery the iab was inserted via the patients "ascending aorta. " after ~10-15 min of counter-pulsation was initiated and during weaning of bypass the autocat2 console alarmed "helium loss. " the md and perfusionist found blood in the helium tubing immediately and the pump was switched off and the iab was removed and replaced successfully. There was a 5 minute delay in iabp therapy. The patient expired 7 hours later. The md and perfusionist stated that the patient was extremely ill and the iab did not contribute to the patient's death.
 
Manufacturer Narrative
(b)(4). Returned for evaluation was a 40cc 8. 0fr fos iab with the supplied return kit. The bladder membrane and bifurcate were wrapped in bubble wrap. Blood was noted within the bladder membrane and short driveline tubing. The short driveline tubing was cut at the bifurcate. The one-way valve was not returned with the device. No kinks or bends were noted to the central lumen upon return. The fos connector and cal key were examined. The gray fos connecter was found recessed 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 abnormalities were noted. The cal key was intact. 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 fos and cal key were connected to the iabp. The pump displayed an "eo" status indicating a potentially dirty fos connector. After cleaning the tip with isopropyl alcohol, the fos was tested again, and the fos status was "ok". See other remarks section. Other remarks: the iab was submerged in water and leak tested using the mdt-50. A leak was found approximately 37. 5cm from the distal tip on the outer lumen of the device. Under microscopic inspection, a puncture consistent with contact from a sharp object was found on the outer lumen. 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 blood in helium pathway is confirmed. A puncture consistent with contact from a sharp object was found on the outer lumen which likely allowed blood to enter the helium pathway. The root cause of the damage is undetermined.
 
Event Description
It has been reported that the event involved a (b)(6) cm in height. While in open heart surgery the iab was inserted via the patients "ascending aorta. " after approximately 10-15 min of counter-pulsation was initiated and during weaning of bypass the autocat2 console alarmed "helium loss. " the md and perfusionist found blood in the helium tubing immediately and the pump was switched off and the iab was removed and replaced successfully. There was a 5 minute delay in iabp therapy. The patient expired 7 hours later. The md and perfusionist stated that the patient was extremely ill and the iab did not contribute to the patient's death.
 
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
anne rosenberger
2400 bernville road
reading, PA 19605
6104783117
MDR Report Key5746317
MDR Text Key48098594
Report Number1219856-2016-00139
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/31/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/23/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2016
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18R14M0026
Other Device ID Number00801902007247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/22/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-