• 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: 7FR 30CC INTRA- AORTIC BALLOOON PRODUCTS

  • 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: 7FR 30CC INTRA- AORTIC BALLOOON PRODUCTS Back to Search Results
Catalog Number IAB-S730C
Device Problem Occlusion Within Device (1423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/29/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that while in the cath lab the medical doctor was not able to "regurge" the balloon. So, the medical doctor requested another iab and used the new iab successfully. Additional information received 11/01/2016. The iab was inserted into the patient via the femoral artery. After not being able to "regurge" the balloon the md removed the iab and sheath. Another iab was prepped inserted via the same insertion site. There was a 10 minute delay / interruption in iabp therapy. There was no harmful outcome to the patient.
 
Manufacturer Narrative
Qn#(b)(4). Evaluation: the reported complaint of unable to aspirate/flush central lumen is not confirmed. However, the device was found kinked and had numerous bends to the central lumen which may have caused the reported complaint. The root cause of the kink/bends is undetermined. The ifu states: "do not remove arrow iab through hemostasis sheath introducer or hemostasis device. Once unwrapped (unfurled), balloon profile will not allow passage through the sheath and attempted removal in this manner may result in arterial tearing, dissection or balloon damage. " 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. Teleflex will continue to monitor for similar reported complaints. Other remarks: conclusion: the reported complaint of unable to aspirate/flush central lumen is not confirmed. However, the device was found kinked and had numerous bends to the central lumen which may have caused the reported complaint. The root cause of the kink/bends is undetermined.
 
Event Description
It was reported that while in the cath lab the md was not able to "regurge" the balloon. So, the md requested another iab and used the new iab successfully. Additional information received 11/01/2016: the iab was inserted into the patient via the femoral artery. After not being able to "regurge" the balloon the md removed the iab and sheath. Another iab was prepped inserted via the same insertion site. There was a 10 minute delay / interruption in iabp therapy. There was no harmful outcome to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameREDIGUARD IAB: 7FR 30CC
Type of DeviceINTRA- AORTIC BALLOOON PRODUCTS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
anne rosenberger
2400 bernville road
reading, PA 19605
6104783117
MDR Report Key6123455
MDR Text Key60745157
Report Number1219856-2016-00269
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K981660
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 10/24/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2018
Device Catalogue NumberIAB-S730C
Device Lot Number18F16D0031
Other Device ID Number00801902002686
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/28/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/19/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-