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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0567
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Chest Tightness/Pressure (2463)
Event Date 08/26/2019
Event Type  Injury  
Manufacturer Narrative
The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Complaint # (b)(4).
 
Event Description
Initially, it was reported that during use on a patient, the intra-aortic balloon pump (iabp) shut down and the patient experienced chest pain.However, it was subsequently clarified by the customer that the registered nurse/csicu (cardiac surgical intensive care unit) surfaced numerous autofill failures and the clinicians opted to take out the intra- aortic balloon catheter (iabc) and discontinued the therapy with no further adverse reaction.In addition, it was also clarified by the customer that the console unit never shut down on the patient; the nurse turned the console off.There was no reported malfunction on the intra-aortic balloon catheter (iabc).
 
Event Description
Initially, it was reported that during use on a patient, the intra-aortic balloon pump (iabp) shut down and the patient experienced chest pain.However, it was subsequently clarified by the customer that the registered nurse/csicu (cardiac surgical intensive care unit) surfaced numerous autofill failures and the clinicians opted to take out the intra- aortic balloon catheter (iabc) and discontinued the therapy with no further adverse reaction.In addition, it was also clarified by the customer that the console unit never shut down on the patient; the nurse turned the console off.There was no reported malfunction on the intra-aortic balloon catheter (iabc).
 
Manufacturer Narrative
Serial #: (b)(4), lot #: 3000084492.The product was returned with the membrane completely unfolded with blood on the exterior of the catheter and between the catheter and the returned maquet sheath.The extracorporeal tubing was found cut at approximately 21.8cm from the rear of the y-fitting.Additionally, 2 catheter kinks were noted at approximately 36.1cm & 76.5cm from the iab tip respectively.The technician attempted to insert a laboratory 0.025¿ guidewire through the inner lumen and was able to successfully insert the guidewire.Obstruction was felt and was cleared.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and one leak was detected on the catheter tubing approximately 76.5cm from the iab tip.The evaluation found a leak on the catheter tubing, but cannot determine if the leak was present at the time of the reported event since there was no reported malfunction of the catheter.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.(b)(4).
 
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Brand Name
SENSATION PLUS 7.5FR. 40CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key9078685
MDR Text Key163088266
Report Number2248146-2019-00749
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K122628
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number0684-00-0567
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2019
Was the Report Sent to FDA? Yes
Date Manufacturer Received11/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age53 YR
Patient Weight91
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