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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 Problem Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/09/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the event involved a patient of (b)(6) in height.The event occurred in the operating room (or).While the intra-aortic balloon (iab) was inserted over the guide wire there was a "feeling that the lumen of the iab was not large enough for the guide wire." as a result another iab was retrieved and used for this patient.The second iab was inserted into the same insertion site; the patient's right femoral artery through a sheath.The iab insertion was successful.There was no reported interruption in intra-aortic balloon pump (iabp) therapy, nor was there patient complications due to the iab tight over the spring wire guide (swg).Medical / surgical intervention was not required and the report states that the patient was not injured.Due to the patients low cardiac output syndrome she did expire and the cardiac surgeon (consultant) noted that the iab did not contribute to the patient's death.
 
Manufacturer Narrative
(b)(4).Teleflex has received the device for analysis.The reported complaint is confirmed a bend was found to the iab and the returned guidewire was unable to fully advance through the central lumen.The root cause of the bend 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.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.
 
Event Description
It was reported that the event involved a patient of (b)(6) in height.The event occurred in the operating room (or).While the intra-aortic balloon (iab) was inserted over the guide wire there was a "feeling that the lumen of the iab was not large enough for the guide wire." as a result another iab was retrieved and used for this patient.The second iab was inserted into the same insertion site; the patient's right femoral artery through a sheath.The iab insertion was successful.There was no reported interruption in intra-aortic balloon pump (iabp) therapy, nor was there patient complications due to the iab tight over the spring wire guide (swg).Medical / surgical intervention was not required and the report states that the patient was not injured.Due to the patients low cardiac output syndrome she did expire and the cardiac surgeon (consultant) noted that the iab did not contribute to the patient's death.
 
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Brand Name
ULTRAFLEX IAB: 7.5FR 40CC
Type of Device
INTRA- 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 Key6360524
MDR Text Key68418853
Report Number1219856-2017-00030
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeGR
PMA/PMN Number
K000729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2017
Device Catalogue NumberIAB-06840-U
Device Lot Number18F15J0021
Other Device ID Number00801902026804
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/22/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/10/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ADRENALINENORADRENALINEDOBUTAMINE
Patient Age66 YR
Patient Weight85
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