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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD LINEAR 7.5 FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD LINEAR 7.5 FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0474
Device Problems Difficult to Insert (1316); Positioning Problem (3009)
Patient Problem Hematoma (1884)
Event Date 07/26/2016
Event Type  malfunction  
Manufacturer Narrative
The device was returned to the manufacturer however, at this time, it has not been evaluated. When an assessment of the affected product is complete a supplemental report with our additional findings will be provided. (b)(4).
 
Event Description
It was intended that this patient was to have a 34cc balloon implanted however during insertion, the 7. 5fr sheath could not be placed successfully and a hematoma occurred. The patient refused to receive another balloon through the opposite femoral artery and as a result iabp therapy concluded.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood found on the exterior of the catheter with the one-way valve attached. The insertion components were also returned. The sheath was not returned for evaluation. The one-way valve was vacuum tested and it held vacuum. The returned sheath was measured and found to within specification. A laboratory insertion test was unable to be performed due to the membrane being unfurled. An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extension tubing was performed and no leaks were detected. A leak may impact the ability to maintain vacuum. We are unable to confirm the reported difficulty during insertion because of the returned condition of the catheter and we are unable to mimic the clinical setting. No nonconformances were found that are considered to be related to the event. (b)(4).
 
Event Description
It was intended that this patient was to have a 34cc balloon implanted however during insertion, the 7. 5fr sheath could not be placed successfully and a hematoma occurred. The patient refused to receive another balloon through the opposite femoral artery and as a result iabp therapy concluded.
 
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Brand NameLINEAR 7.5 FR. 34CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
15 law drive
fairfield, NJ 07004
MDR Report Key5903680
MDR Text Key52980788
Report Number2248146-2016-00066
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
K041281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/10/2018
Device Catalogue Number0684-00-0474
Device Lot Number3000013650
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received09/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/10/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 08/25/2016 Patient Sequence Number: 1
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