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
Catalog Number IAB-05840-LWS
Device Problems Fluid/Blood Leak (1250); No Device Output (1435); Failure to Zero (1683)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/24/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint was reported to teleflex as the "fos would not zero".Based on the reported complaint it was determined to be a not re portable.However, the device was just returned for investigation and blood was noted in the catheter.Based on the blood found in the catheter during our investigation we changed the reporting decision to make this a reportable complaint.There was no report of delay in therapy.There was no report of patient complication or serious injury and death.
 
Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of iab fos would not zero is confirmed.The fos fiber was broken and therefore the light path could not be established between the sensor and the pump.Additionally, upon return, dried blood was noted within the helium pathway and a puncture consistent with damage from the broken fiber was confirmed.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.
 
Event Description
The complaint was reported to teleflex as the "fos would not zero".Based on the reported complaint it was determined to be a not re portable.However, the device was just returned for investigation and blood was noted in the catheter.Based on the blood found in the catheter during our investigation we changed the reporting decision to make this a reportable complaint.There was no report of delay in therapy.There was no report of patient complication or serious injury and death.
 
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 Key8931041
MDR Text Key155525267
Report Number3010532612-2019-00305
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 08/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2020
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F18G0001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2019
Initial Date Manufacturer Received 08/13/2019
Initial Date FDA Received08/26/2019
Supplement Dates Manufacturer Received10/07/2019
Supplement Dates FDA Received10/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-