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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-05830-LWS
Device Problems Device Alarm System (1012); Detachment Of Device Component (1104); Gas Leak (2946)
Patient Problem Air Embolism (1697)
Event Date 01/19/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation. The reported complaint of "balloon had broken off from the metal tip of the catheter" is confirmed based on the customer pictures provided with the complaint report. The root cause of how the bladder detached from the distal tip is undetermined due to the product not being returned for investigation. 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 counter pulsation worked for about 10-15 minutes without any alarm or problems. After about 15 minutes of therapy the intra-aortic balloon pump (iabp) alarmed helium loss. As a result, the iab was removed. The balloon had broken off from the metal tip of the catheter that houses the optical fiber. Patient outcome: the patient is being recovered in therapy sub-intensive department. The catheter was not replaced.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic counter pulsation worked for about 10-15 minutes without any alarm or problems. After about 15 minutes of therapy the intra-aortic balloon pump (iabp) alarmed helium loss. As a result, the iab was removed. The balloon had broken off from the metal tip of the catheter that houses the optical fiber. Patient outcome: the patient is being recovered in therapy sub-intensive department. The catheter was not replaced.
 
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Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 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 Key7219437
MDR Text Key114204688
Report Number1219856-2018-00024
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K021462
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 01/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2018
Device Catalogue NumberIAB-05830-LWS
Device Lot Number18S16K0017
Other Device ID Number00801902034724
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 Received03/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/26/2017
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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