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 30CC; 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 30CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000252
Device Problems No Device Output (1435); Off-Label Use (1494); Failure to Zero (1683)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/25/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by a teleflex sales rep.That an intra-aortic balloon (iab) fiber optic failure occurred.As a result, a new catheter was inserted via the axillary approach.There was no report of patient injury or consequence.This report would not be likely 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.This system does not require the clinician to remove the iab in the event that the fos is lost.It was reported that the patient was going for a heart transplant.The iab would be inserted axillary approach.Per the instructions for use (ifu) this is an off label approach.
 
Manufacturer Narrative
Qn#(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iab fos would not zero is not able to be confirmed.The root cause of the complaint is undetermined.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed 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.
 
Event Description
It was reported by a teleflex sales rep.That an intra-aortic balloon (iab) fiber optic failure occurred.As a result, a new catheter was inserted via the axillary approach.There was no report of patient injury or consequence.This report would not be likely 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.This system does not require the clinician to remove the iab in the event that the fos is lost.It was reported that the patient was going for a heart transplant.The iab would be inserted axillary approach.Per the instructions for use (ifu) this is an off label approach.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FIBEROPTIX ULTRA 8 IAB: 8FR 30CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9644169
MDR Text Key184478779
Report Number3010532612-2020-00007
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902034724
UDI-Public00801902034724
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 01/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN000252
Device Catalogue NumberIAB-05830-LWS
Device Lot NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received02/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-