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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 Problem Fluid Leak (1250)
Patient Problems Venipuncture (2129); No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 05/31/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Teleflex received the device for analysis. The reported complaint that there was a leak at the hub of the central lumen is confirmed. Although, the root cause is undetermined 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. 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 assessed the risk for the reported complaint. There are no new or revised risks. This issue will be monitored for developing trends.
 
Event Description
It was reported that in the department of cardiology the "doctor complained that during use of the intra-aortic balloon (iab) on a patient the heparin connector of the iab had leakage which cause patients bleeding. The doctor replaced a new one to conduct the treatment". There was a reported delay and or interruption in therapy but unknown if the delay caused harm to the patient. The first iab was inserted via the left femoral artery and the second iab was inserted via the right femoral artery. There was no reported patient death, injury or complications.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that in the department of cardiology the "doctor complained that during use of the intra-aortic balloon (iab) on a patient the heparin connector of the iab had leakage which cause patients bleeding. The doctor replaced a new one to conduct the treatment". There was a reported delay and or interruption in therapy but unknown if the delay caused harm to the patient. The first iab was inserted via the left femoral artery and the second iab was inserted via the right femoral artery. There was no reported patient death, injury or complications.
 
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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.
9 plymouth street
everett MA 02149
Manufacturer Contact
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key6611147
MDR Text Key113317514
Report Number1219856-2017-00127
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 06/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2018
Device Catalogue NumberIAB-S840C
Device Lot Number18F16J0027
Other Device ID Number00801902002679
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/20/2016
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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