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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 Known Impact Or Consequence To Patient (2692)
Event Date 07/05/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Teleflex received the device for investigation. The reported complaint of fos would not zero is confirmed. Although, the root cause of the fos fiber being broken could not be determined the light path could not be established between the sensor and the pump. 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. Teleflex assessed the risk for the reported complaint. There are no new or revised risk. This issue will be monitored for any developing trends.
 
Event Description
It was reported that the event involved a fiberoptic intra-aortic balloon (iab) that failed to register the fiber optic sensor (fos). There was no patient interaction. The rn stated that the event took place in the cath lab and occurred prior to the insertion of the iab. The fos failed to register and as a result, another iab was used. There was a delay of ten minutes but no patient complications and no medical/surgical intervention required.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the event involved a fiberoptic intra-aortic balloon (iab) that failed to register the fiber optic sensor (fos). There was no patient interaction. Additional information received: the rn stated that the event took place in the cath lab and occurred prior to the insertion of the iab. The fos failed to register and as a result, another iab was used. There was a delay of ten minutes but no patient complications and no medical/surgical intervention required.
 
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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 Key6757351
MDR Text Key195845231
Report Number1219856-2017-00177
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 07/05/2017
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 Date03/31/2019
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F17C0058
Other Device ID Number00801902007247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2017
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? Yes
Date Device Manufactured03/24/2017
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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