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. ULTRAFLEX IAB: 7.5FR 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. ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-06840-U
Device Problems Occlusion Within Device (1423); No Device Output (1435)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/05/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the md that he is with a patient on the intra-aortic balloon pump (iabp) and the arterial pressure (ap) waveform disappeared.The clinical support specialist (css) asked md to attempt to withdraw blood from the central lumen.The md stated he was able to withdraw a very small amount, but he was not able to flush the line.The css told the md the central lumen is most likely clotted, and he should not try to force the flush.The md was able to withdraw blood and easily flush the side arm of the sheath, but the waveform was not great.The css asked him to place an alternate arterial line for monitoring and the md stated he would place a radial arterial line and connect it to the pump.The arterial line was placed without difficulty.There were no patient complications reported.
 
Manufacturer Narrative
Qn# (b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iab central lumen occluded is not able to be confirmed.The root cause of the complaint is undetermined.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.The reported complaint will be monitored for any developing trends.No further action required at this time.
 
Event Description
It was reported by the md that he is with a patient on the intra-aortic balloon pump (iabp) and the arterial pressure (ap) waveform disappeared.The clinical support specialist (css) asked md to attempt to withdraw blood from the central lumen.The md stated he was able to withdraw a very small amount, but he was not able to flush the line.The css told the md the central lumen is most likely clotted, and he should not try to force the flush.The md was able to withdraw blood and easily flush the side arm of the sheath, but the waveform was not great.The css asked him to place an alternate arterial line for monitoring and the md stated he would place a radial arterial line and connect it to the pump.The arterial line was placed without difficulty.There were no patient complications reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ULTRAFLEX IAB: 7.5FR 40CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key7306957
MDR Text Key101573158
Report Number2518433-2018-00010
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K000729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/05/2018
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 Date06/30/2018
Device Catalogue NumberIAB-06840-U
Device Lot Number18F16F0053
Other Device ID Number00801902026804
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/05/2018
Initial Date FDA Received03/01/2018
Supplement Dates Manufacturer Received03/20/2018
Supplement Dates FDA Received03/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-