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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 Problems Difficult to Remove (1528); Communication or Transmission Problem (2896)
Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)
Event Date 01/10/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon (iab) zeroed prior to insertion then shortly after pumping a message fiber optic sensor (fos) signal weak and the pump switched to transducer waveform.The patient was stable using the transducer waveform.Additional information was received by the biomedical engineer.It was reported that the event occurred during removal of the iab.After the procedure was finished, the staff had difficulty removing the iab.As a result, the patient was sent to the operating room (or) to be "cut down", to remove the iab.There was no patient death reported.
 
Event Description
It was reported that the intra-aortic balloon (iab) zeroed prior to insertion then shortly after pumping a message fiber optic sensor (fos) signal weak and the pump switched to transducer waveform.The patient was stable using the transducer waveform.Additional information was received by the biomedical engineer.It was reported that the event occurred during removal of the iab.After the procedure was finished, the staff had difficulty removing the iab.As a result, the patient was sent to the operating room (or) to be "cut down", to remove the iab.There was no patient death reported.
 
Manufacturer Narrative
(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iab removal difficulty is not able to be c onfirmed.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.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.
 
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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 Key8301560
MDR Text Key134884863
Report Number3010532612-2019-00016
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,health
Type of Report Initial,Followup
Report Date 01/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/28/2020
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F18C0015
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/10/2019
Initial Date FDA Received02/04/2019
Supplement Dates Manufacturer Received03/04/2019
Supplement Dates FDA Received03/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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