• 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); Material Rupture (1546)
Patient Problems Congestive Heart Failure (1783); Low Cardiac Output (2501)
Event Date 02/02/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). See also mdr #1219856-2017-00059.
 
Event Description
It was reported that the event involved a patient of 70 inches in height. The intra-aortic balloon (iab) was inserted via sheath into the patient's right axillary artery on (b)(6) 2017 in the operating room (or). That evening, during therapy post insertion, the balloon ruptured and was removed by the medical doctor (md). The sheath remained in place. The patient was taken to cath lab on (b)(6) 2017 and a new iab was inserted via sheath. The length of time in use prior to event was less than 19 hours. There was an interruption in intra-aortic balloon pump (iabp) therapy for less than 11 hours. There was no reported patient death, injury or complications.
 
Manufacturer Narrative
(b)(4). Teleflex received the device for analysis. 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. The appearance of the abraded area is consistent with repeated contact with calcified plaque on the aortic wall. No further action required. A device history report review was performed and it did not reveal any manufacturing related issues. Teleflex assessed the risk for the reported complaint. There are no new or revised risks. Other remarks: please refer to mdr #1219856-2017-00059/(b)(4) related to this complaint.
 
Event Description
It was reported that the event involved a patient of (b)(6) inches in height. The intra-aortic balloon (iab) was inserted via sheath into the patient's right axillary artery on (b)(6) 2017 in the operating room (or). That evening, during therapy post insertion, the balloon ruptured and was removed by the medical doctor (md). The sheath remained in place. The patient was taken to cath lab on (b)(6) 2017 and a new iab was inserted via sheath. The length of time in use prior to event was less than 19 hours. There was an interruption in intra-aortic balloon pump (iabp) therapy for less than 11 hours. There was no reported patient death, injury or complications.
 
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
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key6437359
MDR Text Key71000102
Report Number1219856-2017-00058
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2018
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F16J0023
Other Device ID Number00801802007247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/19/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-