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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-S840C
Device Problems Device Alarm System (1012); Fluid Leak (1250); Material Rupture (1546)
Patient Problem Venipuncture (2129)
Event Date 01/14/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation therefore the reported complaint of iab blood in helium pathway 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 that an intra-aortic balloon (iab) was placed in a patient and the doctor found blood was in the catheter, the catheter was removed. The doctor found that the catheter was broken. As a result, the iab was replaced with a new iab successfully. There was no reported patient death. Additional information received when the doctor exchanged the iab the opposite groin was used.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that an intra-aortic balloon (iab) was placed in a patient and the doctor found blood was in the catheter, the catheter was removed. The doctor found that the catheter was broken. As a result, the iab was replaced with a new iab successfully. There was no reported patient death. Additional information received when the doctor exchanged the iab the opposite groin was used.
 
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Brand NameREDIGUARD IAB: 8FR 40CC
Type of DeviceSYSTEM, 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 Key7252746
MDR Text Key113554236
Report Number1219856-2018-00026
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCH
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 01/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2019
Device Catalogue NumberIAB-S840C
Device Lot Number18F17H0020
Other Device ID Number00801902002679
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/10/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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