Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000254
Device Problem Fluid/Blood Leak (1250)
Patient Problem Death (1802)
Event Date 08/21/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
A medwatch report was received under (b)(4).It was reported that the intra-aortic balloon (iab) fiberoptic was not zeroed prior to insertion.The nurse disconnected and reconnected the fiberoptic and cal key with no change.As a result, the transducer was utilized.The sample was received and upon investigation it was noted that blood had entered the helium pathway.Due to the returned state of the device, the report was made reportable.The patient was declared brain dead.The staff stated there was no harm to the patient.The intra-aortic balloon pump (iabp) functioned correctly and was placed as a life saving measure.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.
 
Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of iab fos would not zero is not able to be confirmed.The iabc was returned too damaged to analyze.An fos failure was unable to be determined due to the returned state of the device.Additionally, upon receipt there was dried blood noted within the helium pathway; however, the cause could not be confidently determined due to the returned state of the device.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 revived risk.This will be monitored for any developing trends.
 
Event Description
A medwatch report was received under (b)(4).It was reported that the intra-aortic balloon (iab) fiberoptic was not zeroed prior to insertion.The nurse disconnected and reconnected the fiberoptic and cal key with no change.As a result, the transducer was utilized.The sample was received and upon investigation it was noted that blood had entered the helium pathway.Due to the returned state of the device, the report was made reportable.The patient was declared brain dead.The staff stated there was no harm to the patient.The intra-aortic balloon pump (iabp) functioned correctly and was placed as a life saving measure.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11307624
MDR Text Key231576746
Report Number3010532612-2021-00035
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 01/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2022
Device Model NumberIPN000254
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F20E0023
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2020
Date Manufacturer Received02/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age51 YR
-
-