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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC INTRA- AORTIC BALLOON

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ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC INTRA- AORTIC BALLOON Back to Search Results
Catalog Number IAB-06840-U
Device Problems Fluid Leak (1250); Material Rupture (1546)
Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Respiratory Failure (2484)
Event Date 06/09/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation therefore the reported complaint of blood in the 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. Other remarks: medwatch report #: mw5070552.
 
Event Description
It was reported via a user facility report (medwatch report) that a patient of (b)(6)cm in height had an intra-aortic balloon (iab) placed via the right femoral artery. The iab was placed after the patient had a cardiac arrest. The iab ruptured and it was decided not to replace the iab. Additional information received on 7/17/2017: it was reported that the patient expired on (b)(6) 2017 the patient no longer had the device.
 
Manufacturer Narrative
(b)(4). Other remarks: medwatch report #: mw5070552.
 
Event Description
It was reported via a user facility report (medwatch report) that a patient of 179cm in height had an intra-aortic balloon (iab) placed via the right femoral artery. The iab was placed after the patient had a cardiac arrest. The iab ruptured and it was decided not to replace the iab. Additional information received on 7/17/2017: it was reported that the patient expired on (b)(6) 2017 the patient no longer had the device.
 
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Brand NameULTRAFLEX IAB: 7.5FR 40CC
Type of DeviceINTRA- AORTIC BALLOON
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 Key6723587
MDR Text Key210984255
Report Number1219856-2017-00156
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K000729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/23/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Catalogue NumberIAB-06840-U
Device Lot Number18F17B0021
Other Device ID Number00801902026804
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 Received08/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/10/2017
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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