• 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. REDIGUARD IAB: 8FR 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. REDIGUARD IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-S840C
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/06/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon (iab) catheter couldn't be advanced through the sheath. As a result, a new kit was used and successfully inserted. Patient outcome reported as fine. There was no report of patient complication, serious injury or death.
 
Event Description
It was reported that the intra-aortic balloon (iab) catheter couldn't be advanced through the sheath. As a result, a new kit was used and successfully inserted. Patient outcome reported as fine. There was no report of patient complication, serious injury or death.
 
Manufacturer Narrative
(b)(4). Teleflex received the device for investigation. The reported complaint that there was a leak at the hub of the central lumen is confirmed. During functional testing, a crack was found at the injection site of the bifurcate for the central lumen. This crack allowed a leak to occur at the injection site of the central lumen. Therefore, the root cause of how the crack occurred 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. However, the received product did not meet specifications during the complaint investigation due to the crack found on the bifurcate. A nonconformance has been initiated to investigate the root cause. The reported complaint will be monitored for any developing trends.
 
Manufacturer Narrative
(b)(4). This follow up report #2 is being resubmitted to you because the information contained in the previous follow up #1 report that was submitted to you included inaccurate information. Please find the updated, corrected "additional manufacturer narrative" in this report. Teleflex received the device for investigation. The reported complaint of iab could not advance in sheath is confirmed. The central lumen was found kinked, which blocked the guidewire from advancing and could lead to potential sheath insertion difficulty. The iab must be inserted over a guidewire and a kinked/blocked central lumen would prevent the device from fully advancing in the patient. The root cause of how the central lumen became kink 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. Teleflex assessed the risk for the reported complaint. There are no new or revised risks. This will be monitored for any developing trends. No further action required at this time.
 
Event Description
It was reported that the intra-aortic balloon (iab) catheter couldn't be advanced through the sheath. As a result, a new kit was used and successfully inserted. Patient outcome reported as fine. There was no report of patient complication, serious injury or death.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameREDIGUARD IAB: 8FR 40CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key7655920
MDR Text Key113049310
Report Number3010532612-2018-00192
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K981660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 06/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2019
Device Catalogue NumberIAB-S840C
Device Lot Number18F17F0001
Other Device ID Number00801902002679
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/01/2018
Is This a Reprocessed and Reused Single-Use Device? No

-
-