• 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 Complete Blockage (1094); Difficult to Flush (1251)
Patient Problems No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462)
Event Date 08/08/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). For complaint related to the same patient and event see mdr #3010532612-2019-00329 and (b)(4).
 
Event Description
It was reported by the rn that the central lumen on the intra-aortic balloon (iab) is clotted. The rn stated that they are losing the arterial pressure (ap) waveform on the iab. The rn was not able to draw any blood back, and it would not flush. Patient is stable and scheduled to have the iab removed tomorrow. They were using saline only in the pressure bag, but the patient was systemically heparinized. As a result, an alternate a line will be inserted. There was no report of delay in therapy. There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(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. 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. Other remarks: for complaint related to the same patient and event see mdr #3010532612-2019-00329 and tc #(b)(4).
 
Event Description
It was reported by the rn that the central lumen on the intra-aortic balloon (iab) is clotted. The rn stated that they are losing the arterial pressure (ap) waveform on the iab. The rn was not able to draw any blood back, and it would not flush. Patient is stable and scheduled to have the iab removed tomorrow. They were using saline only in the pressure bag, but the patient was systemically heparinized. As a result, an alternate a line will be inserted. There was no report of delay in therapy. There was no report of patient complications, serious injury or death.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameULTRAFLEX IAB: 7.5FR 40CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8947043
MDR Text Key156112090
Report Number3010532612-2019-00303
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K000729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Catalogue NumberIAB-06840-U
Device Lot Number18F17L0046
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2019
Is This a Reprocessed and Reused Single-Use Device? No

-
-