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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 Occlusion Within Device (1423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/25/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon (iab) was placed on a patient and the fiber optic sensor (fos) signal was lost. They then transduced the arterial pressure (ap) signal from the central lumen. However, the signal from the central lumen appears much dampened despite several different flushes. The deflation timing also appears late. After switching to the alternate ap source (radial a-line), and with further discussion, it was determined that the deflation timing is correct. The pump is providing good support for the patient. The iab was continued to be used and was not replaced. No patient complications. No delay/interruption in therapy. No reported patient death or serious injury. There was no medical intervention required.
 
Event Description
It was reported that the intra-aortic balloon (iab) was placed on a patient and the fiber optic sensor (fos) signal was lost. They then transduced the arterial pressure (ap) signal from the central lumen. However, the signal from the central lumen appears much dampened despite several different flushes. The deflation timing also appears late. After switching to the alternate ap source (radial a-line), and with further discussion, it was determined that the deflation timing is correct. The pump is providing good support for the patient. The iab was continued to be used and was not replaced. No patient complications. No delay/interruption in therapy. No reported patient death or serious injury. There was no medical intervention required.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation. Therefore the reported complaint of iab central lumen occluded is not able to be confirmed. The root cause of the complaint could not be determined. 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. If the product is returned at a later date, a full investigation of the sample will be completed. No further action required at this time.
 
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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
MDR Report Key7284977
MDR Text Key100667570
Report Number3010532612-2018-00023
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/21/2018
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 Number18F17E0056
Other Device ID Number00801902007247
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2018
Is This a Reprocessed and Reused Single-Use Device? No

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