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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
Model Number IPN000254
Device Problems No Device Output (1435); Unable to Obtain Readings (1516)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/09/2020
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).Other remarks: see mdr# 3010532612-2020-00293 (b)(4) as the reports are related to the same patient.This report would not be likely to cause or contribute to a death or serious injury, and if it were to reoccur, it would be unlikely to cause or contribute to a death or serious injury.A fiber optic sensor (fos) not connecting cannot in itself cause or contribute to a patient death or serious injury.The fos is a portion of the catheter that monitors the patient's arterial pressure.When the fiber optic pressure signal is not available, the intra-aortic balloon (iab) is still able to be used since an arterial pressure signal is available through the central lumen.Iab therapy continues to the patient uninterrupted.
 
Event Description
It was reported that seven minutes after insertion of the intra-aortic balloon (iab) the intra-aortic balloon pump (iabp) reported the error: fos ll.The staff also had difficulty to carry out the wash.As a result, the iab was removed and replaced to complete the procedure.There was no report of patient complications serious injury or death.
 
Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of iab fos signal lost is confirmed.The fos fiber was broken and therefore the light path could not be established between the sensor and the pump.The root cause of the broken fiber 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.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.Other remarks: see mdr# 3010532612-2020-00293 (tc1900079462) as the reports are related to the same patient.This report would not be likely to cause or contribute to a death or serious injury, and if it were to reoccur, it would be unlikely to cause or contribute to a death or serious injury.A fiber optic sensor (fos) not connecting cannot in itself cause or contribute to a patient death or serious injury.The fos is a portion of the catheter that monitors the patient's arterial pressure.When the fiber optic pressure signal is not available, the intra-aortic balloon (iab) is still able to be used since an arterial pressure signal is available through the central lumen.Iab therapy continues to the patient uninterrupted.
 
Event Description
It was reported that seven minutes after insertion of the intra-aortic balloon (iab) the intra-aortic balloon pump (iabp) reported the error: fos ll.The staff also had difficulty to carry out the wash.As a result, the iab was removed and replaced to complete the procedure.There was no report of patient complications serious injury or death.
 
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Brand Name
FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10622142
MDR Text Key209652796
Report Number3010532612-2020-00303
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902007247
UDI-Public00801902007247
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,foreig
Type of Report Initial,Followup
Report Date 09/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2021
Device Model NumberIPN000254
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F20A0020
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2020
Initial Date Manufacturer Received 09/24/2020
Initial Date FDA Received10/02/2020
Supplement Dates Manufacturer Received11/03/2020
Supplement Dates FDA Received11/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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