• 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 30CC 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 30CC INTRA- AORTIC BALLOON FIBER OPTIC Back to Search Results
Catalog Number IAB-05830-LWS
Device Problems Unable to Obtain Readings (1516); Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/05/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via a hot line call from the perfusionist that on (b)(6) 2017 while in the operating room (or) with a patient having surgery; they needed to place an intra-aortic balloon (iab) to assist in getting the patient off bypass. The perfusionist told the clinical support specialist that they were inserting a fiber optic sensor (fos) iab since the patient was under (b)(6) in height. They tried to make the fos connection to the pump prior to insertion. They heard a click, but no audible tone and the icon did not change color; it remained a black bulb in a blue square fiberoptix iab not connected. They tried to reconnect the fos but still no connection. As a result a second iab was retrieved and the appropriate connection to the pump was achieved. The second iab is still in the patient and the pump is functioning appropriately. The perfusionist wanted to see if there was any other troubleshooting they could have done at the time to salvage the fiberoptic. He states that it seems like about one in every four fiberoptic iabs fails. The css and perfusionist discussed the following: making the connection to the pump, checking to see if the fos connection is recessed, and trying to make the connection to a second pump. The css explained that there are two places that could cause problems for connection, one is the connection in the pump; it may be dirty and needs to be cleaned or changed. Their biomed should have the recommendations for frequency of cleaning and changing the fos connection. The perfusionist stated that the connections were all changed out last year. The css said that the second place that could be a problem is the blue connector itself; if the optical connection is recessed into the blue holder, the fos will not make a good connection to the pump. The css told the perfusionist that the user could continue to use the iab, but they would need to utilize the central lumen for the arterial pressure waveform for timing.
 
Manufacturer Narrative
(b)(4). Teleflex has received the device for analysis. The reported complaint "fiberoptix iab not connected" was confirmed. The fos was returned with a recessed connector; therefore, a light path could not be established between the sensor and the pump. The fiber was found intact and functional. The root cause of the recessed fos 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. Teleflex will continue to monitor for any developing trends.
 
Event Description
It was reported via a hot line call from the perfusionist that on (b)(6) 2017 while in the operating room (or) with a patient having surgery; they needed to place an intra-aortic balloon (iab) to assist in getting the patient off bypass. The perfusionist told the clinical support specialist that they were inserting a fiber optic sensor (fos) iab since the patient was under 160 cm in height. They tried to make the fos connection to the pump prior to insertion. They heard a click, but no audible tone and the icon did not change color; it remained a black bulb in a blue square fiberoptix iab not connected. They tried to reconnect the fos but still no connection. As a result a second iab was retrieved and the appropriate connection to the pump was achieved. The second iab is still in the patient and the pump is functioning appropriately. The perfusionist wanted to see if there was any other troubleshooting they could have done at the time to salvage the fiberoptic. He states that it seems like about one in every four fiberoptic iabs fails. The css and perfusionist discussed the following: making the connection to the pump, checking to see if the fos connection is recessed, and trying to make the connection to a second pump. The css explained that there are two places that could cause problems for connection, one is the connection in the pump; it may be dirty and needs to be cleaned or changed. Their biomed should have the recommendations for frequency of cleaning and changing the fos connection. The perfusionist stated that the connections were all changed out last year. The css said that the second place that could be a problem is the blue connector itself; if the optical connection is recessed into the blue holder, the fos will not make a good connection to the pump. The css told the perfusionist that the user could continue to use the iab, but they would need to utilize the central lumen for the arterial pressure waveform for timing.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 30CC
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 Key6285896
MDR Text Key66045375
Report Number1219856-2017-00005
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2018
Device Catalogue NumberIAB-05830-LWS
Device Lot Number18F16F0028
Other Device ID Number00801902034724
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/17/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-