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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 SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-05840-LWS
Device Problem Connection Problem (2900)
Patient Problems Cardiac Arrest (1762); Myocardial Infarction (1969)
Event Date 07/17/2017
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4). Teleflex received the device for investigation. The reported complaint of "did not detect" the fos is confirmed. Although, the root cause of the recessed fos is undetermined 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. 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. A nonconformance has been initiated to further investigate the cause of the issue. The complaint will be monitored for any developing trends. This issue will be monitored for any developing trends.
 
Event Description
It was reported that the fiber optic sensor (fos) balloon did not work (it did not detect the optical fiber). As a result, another catheter without optical fiber was used and it worked only in pressure. The problem was encountered when inserting and extracting the connector. The pump alarmed: fiber optic sensor not detected. Patient presented with an acute myocardial infarction and a cardiac arrest. A death was reported but per (b)(6), head of the department the device did not contribute to the patient's death.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the fiber optic sensor (fos) balloon did not work (it did not detect the optical fiber). As a result, another catheter without optical fiber was used and it worked only in pressure. The problem was encountered when inserting and extracting the connector. The pump alarmed: fiber optic sensor not detected. Patient presented with an acute myocardial infarction and a cardiac arrest. A death was reported but per dr. (b)(6), head of the department the device did not contribute to the patient's death.
 
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Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 40CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
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 Key6823780
MDR Text Key248242265
Report Number1219856-2017-00190
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeIT
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 08/03/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2017
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18S16F0025
Other Device ID Number00801902007247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2017
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

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