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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0567
Device Problems Bent (1059); Difficult to Insert (1316)
Patient Problem Hematoma (1884)
Event Date 08/26/2016
Event Type  Injury  
Manufacturer Narrative
Correction: date was not entered in the initial mdr. Manufacturer date: 08/26/2016.
 
Event Description
The doctor attempted to insert the sheath for an iab and was unable to achieve access as the sheath was bent. They retrieved another sheath but were still unable to complete insertion. At some point, the patient developed a hematoma at the entree site. According to the scrub tech the hematoma was not due to the difficulties with the sheath but rather due to the patients¿ very tortuous anatomy. Being unable to insert the second sheath, they opted not to use the iab at all.
 
Manufacturer Narrative
The device is promised to return to the manufacturer however it has not been received and at this time, we're unable to complete an evaluation on the affected product. When its' provided we will send a supplemental report with additional findings. We continue in our efforts to follow up with the customer for its' return. (b)(4).
 
Event Description
The doctor attempted to insert the sheath for an iab and was unable to achieve access as the sheath was bent. They retrieved another sheath but were still unable to complete insertion. At some point, the patient developed a hematoma at the entree site. According to the scrub tech the hematoma was not due to the difficulties with the sheath but rather due to the patient's very tortuous anatomy. Being unable to insert the second sheath, they opted not to use the iab at all.
 
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Brand NameSENSATION PLUS 7.5FR. 40CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key5968012
MDR Text Key268934954
Report Number2248146-2016-00077
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122628
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0684-00-0567
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/21/2016 Patient Sequence Number: 1
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