• 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 INTRA- AORTIC BALLOON FIBER OPTIC

  • 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 INTRA- AORTIC BALLOON FIBER OPTIC Back to Search Results
Catalog Number IAB-05840-LWS
Device Problems Fluid Leak (1250); Difficult to Remove (1528); Material Rupture (1546)
Patient Problems Perforation of Vessels (2135); Injury (2348); Ischemic Heart Disease (2493)
Event Date 11/13/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon (iab) was inserted via a sheath into the patient's left femoral artery. After 36 hours of intra-aortic balloon pump (iabp) therapy blood was found in the helium tubing and the pump alarmed "stop assist". The md attempted to remove the balloon without success; the angiography attempt was impossible. As a result, the patient was taken to the cardio surgery department for vascular surgery. During the surgery the left common femoral artery was enlarged the iab was removed. The surgeon repaired the common femoral artery with a patch. According to the report, "after the iab was removed there was a visual examination and the catheter was found with a rupture of the balloon with a lot inside. " the patient did not receive a second iab and there was an interruption in iabp therapy. Pump strips were generated and are not available for review. X-rays were performed during the removal attempt. The x-ray findings are described as normal. The x-rays are available for review. There was no reported patient death. The patient outcome is listed as fine.
 
Manufacturer Narrative
Qn#(b)(4). Teleflex received the device for an analysis. The reported complaint of blood in the helium pathway is confirmed based on a visual inspection of the device. Blood was noted on the interior of the returned bladder membrane; however, the device could not be functionally tested due to the damaged state of the device upon return. The root cause of the complaint is undetermined. A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings. The device passed all manufacturing specifications prior to release. No further action is required at this time. Teleflex will continue to monitor for similar reports.
 
Event Description
It was reported that the intra-aortic balloon (iab) was inserted via a sheath into the patient's left femoral artery. After 36 hours of intra-aortic balloon pump (iabp) therapy blood was found in the helium tubing and the pump alarmed "stop assist". The md attempted to remove the balloon without success; the angiography attempt was impossible. As a result, the patient was taken to the cardio surgery department for vascular surgery. During the surgery the left common femoral artery was enlarged the iab was removed. The surgeon repaired the common femoral artery with a patch. According to the report, "after the iab was removed there was a visual examination and the catheter was found with a rupture of the balloon with a lot inside. " the patient did not receive a second iab and there was an interruption in iabp therapy. Pump strips were generated and are not available for review. X-rays were performed during the removal attempt. The x-ray findings are described as normal. The x-rays are available for review. There was no reported patient death. The patient outcome is listed as fine.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 40CC
Type of DeviceINTRA- AORTIC BALLOON FIBER OPTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
carmen sherman
3015 carrington mill blvd
morrisville, PA 27560
6104783117
MDR Report Key6194205
MDR Text Key62964957
Report Number1219856-2016-00293
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeIT
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 12/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2018
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F16C0052
Other Device ID Number00801902007247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/30/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/21/2016 Patient Sequence Number: 1
-
-