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 Problems Fluid/Blood Leak (1250); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/01/2020
Event Type  malfunction  
Manufacturer Narrative
Qn#(b)(4).
 
Event Description
The report was received from a user facility report (ufr)/medwatch (b)(4).It was reported that the intra-aortic balloon (iab) was inserted into the patient's left femoral artery and the balloon had ruptured and blood was noted in the helium tubing.As a result, the iab was removed and replaced with an 8fr sheath using the same insertion site.There was no report of patient complications, serious injury or death.
 
Event Description
The report was received from a user facility report (ufr)/medwatch 4100070000-2020-8025.It was reported that the intra-aortic balloon (iab) was inserted into the patient's left femoral artery and the balloon had ruptured and blood was noted in the helium tubing.As a result, the iab was removed and replaced with an 8fr sheath using the same insertion site.There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4).No iab parts was returned to teleflex chelmsford for investigation.The reported complaint of iab blood in helium pathway is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.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 revived risk.This will be monitored for any developing trends.
 
Event Description
The report was received from a user facility report (ufr)/medwatch (b)(4).It was reported that the intra-aortic balloon (iab) was inserted into the patient's left femoral artery and the balloon had ruptured and blood was noted in the helium tubing.As a result, the iab was removed and replaced with an 8fr sheath using the same insertion site.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 blood in helium pathway is confirmed.The iabc bladder had a full thickness abrasion, which caused blood to enter the helium pathway.The appearance of the abraded area is consistent with repeated contact with calcified plaque on the aortic wall.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.
 
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 Key10071605
MDR Text Key191980268
Report Number3010532612-2020-00126
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 user facility
Type of Report Initial,Followup,Followup
Report Date 05/01/2020
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 Date09/30/2021
Device Model NumberIPN000254
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F19K0026
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2020
Initial Date Manufacturer Received 05/01/2020
Initial Date FDA Received05/19/2020
Supplement Dates Manufacturer Received06/19/2020
07/30/2020
Supplement Dates FDA Received06/19/2020
08/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age92 YR
-
-