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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

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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 Failure to Zero (1683); Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/06/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation therefore the reported complaint of fos would not zero is not able to be confirmed. The root cause of the complaint is undetermined. A device history record (dhr) review was conducted for the lot number with no relevant findings. The device passed all manufacturing specifications prior to release. The reported complaint will be monitored for any developing trends. Other remarks: 1219856-2017-00182 and (b)(4).
 
Event Description
It was reported that the blue fiber optic sensor (fos) sensor was connected to the pump before insertion but the sensor was not detected from pump. The cal key was connected and detected. No automatic or manual zeroing could be done. Therefore another intra-aortic balloon catheter was used. Patient outcome is listed as "okay". There was no reported death or serious injury. A report in delay of therapy but no complications to the patient.
 
Manufacturer Narrative
Qn#(b)(4). Other remarks: 1219856-2017-00182 and tc (b)(4).
 
Event Description
It was reported that the blue fiber optic sensor (fos) sensor was connected to the pump before insertion but the sensor was not detected from pump. The cal key was connected and detected. No automatic or manual zeroing could be done. Therefore another intra-aortic balloon catheter was used. Patient outcome is listed as "okay". There was no reported death or serious injury. A report in delay of therapy but no complications to the patient.
 
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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 Key6757527
MDR Text Key247109775
Report Number1219856-2017-00179
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeGM
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 07/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F17E0050
Other Device ID Number00801902007247
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/25/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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