• 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
Catalog Number IAB-05830-LWS
Device Problems Device Alarm System (1012); Fluid Leak (1250); Material Rupture (1546)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 05/04/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Teleflex received the device for evaluation. The reported complaint of blood in helium pathway is confirmed. The iab bladder has a full thickness abrasion which allowed blood to enter the iab. Under microscopic inspection, abrasions were observed to the bladder. 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 and there are no new or revised risks. No further action required.
 
Event Description
It was reported the "intra-aortic balloon (iab) catheter ruptured during therapy". "the bedside nurse heard the alarm, and saw blood begin to back up, turned off and unplugged the helium line, and phoned the senior resident for emergent removal. The medical doctor was unable to re-insert another balloon due to patient's vascular anatomy". There was a reported delay in therapy but no complications or death reported. Insertion site was the right femoral artery. The intra-aortic balloon pump alarmed "helium loss". Patient outcome reported to be "still alive and recovering".
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the "intra-aortic balloon (iab) catheter ruptured during therapy". "the bedside nurse heard the alarm, and saw blood begin to back up, turned off and unplugged the helium line, and phoned the senior resident for emergent removal. The medical doctor was unable to re-insert another balloon due to patient's vascular anatomy". There was a reported delay in therapy but no complications or death reported. Insertion site was the right femoral artery. The intra-aortic balloon pump alarmed "helium loss". Patient outcome reported to be "still alive and recovering".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 30CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key6615068
MDR Text Key130361517
Report Number1219856-2017-00110
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2018
Device Catalogue NumberIAB-05830-LWS
Device Lot Number18F16F0035
Other Device ID Number00801902034724
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-