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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 30CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 30CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-06830-U
Device Problems Device Alarm System (1012); Fluid Leak (1250); Material Rupture (1546)
Patient Problems Death (1802); Myocardial Infarction (1969)
Event Date 01/10/2018
Event Type  Death  
Manufacturer Narrative
(b)(4). Teleflex received the device for investigation. The reported complaint of blood in the helium pathway is confirmed. The bladder had a full thickness abrasion which allowed blood to enter the iab. The appearance of the abraded area is consistent with repeated contact with calcified plaque on the aortic wall. 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. No further action required.
 
Event Description
It was reported that the cardiologist inserted an intra-aortic balloon (iab) on a patient of 155 cm in height after a cardiac catheterization for cardiac support. After about 6 hours of usage the pump alarmed for blood in line. The cardiologist removed the catheter and found balloon broken. Patient outcome: it was reported that the patient deceased.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the cardiologist inserted an intra-aortic balloon (iab) on a patient of (b)(6) in height after a cardiac catheterization for cardiac support. After about 6 hours of usage the pump alarmed for blood in line. The cardiologist removed the catheter and found balloon broken. Patient outcome: it was reported that the patient deceased.
 
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Brand NameULTRAFLEX IAB: 7.5FR 30CC
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 Key7238372
MDR Text Key106181944
Report Number2518433-2018-00004
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K000729
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 01/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2019
Device Catalogue NumberIAB-06830-U
Device Lot Number18F17F0047
Other Device ID Number00801902003751
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/30/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/02/2018 Patient Sequence Number: 1
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