• 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 N/A
Device Problems Entrapment of Device (1212); Fluid Leak (1250); Material Rupture (1546)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Thrombus (2101); Needle Stick/Puncture (2462)
Event Date 11/03/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported "after 10 minutes of use of the intra-aortic balloon (iab) catheter the balloon of the catheter has holed. " additional information received: at the end of the procedure it was difficult to remove the catheter because there was a coagulation on the tip. An intervention was performed a small cut to allow the extraction of the catheter. Surgical repair at access site. There was no reported patient death. Patient outcome reported as recovery.
 
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. If the product is returned at a later date, a full investigation of the sample will be completed. 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.
 
Event Description
It was reported "after 10 minutes of use of the intra-aortic balloon (iab) catheter the balloon of the catheter has holed. " additional information received: at the end of the procedure it was difficult to remove the catheter because there was a coagulation on the tip. An intervention was performed a small cut to allow the extraction of the catheter. Surgical repair at access site. There was no reported patient death. Patient outcome reported as recovery.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 40CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8079553
MDR Text Key127423649
Report Number3010532612-2018-00357
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,foreig
Type of Report Initial,Followup
Report Date 11/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2018
Device Model NumberN/A
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18S16J0018
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/03/2019
Is This a Reprocessed and Reused Single-Use Device? No

-
-