Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD MEGA 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DATASCOPE FAIRFIELD MEGA 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0497
Device Problems Inflation Problem (1310); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/04/2017
Event Type  malfunction  
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.(b)(4).
 
Event Description
It was reported, by the customer, that upon insertion of the intra-aortic balloon (iab) there was difficulty passing through the 8 fr sheath.At that time the iab was removed and re-inserted into a 9 fr sheath however would not inflate.A new iab was utilized and worked successfully.There was no harm or injury to the patient.
 
Manufacturer Narrative
(b)(4).The product was returned with the membrane completely unfolded and traces of blood on the exterior of the catheter.The sheath was not returned for evaluation.One kink was found on the catheter tubing near the y-fitting approximately 76.7cm from the iab tip.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 and extracorporeal tubing was performed and no leaks were detected.A leak may impact the ability to maintain vacuum.The iab was placed on the cs300 pump and the iab fully inflated.No alarm sounded from the pump.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.The evaluation determined there was a kink in the catheter.It is difficult to determine when or how a kink in the catheter occurs.Although we did not repeat the event in the laboratory setting, a kink in the catheter can cause inflation difficulty or an alarm.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.Complaint # (b)(4); record # (b)(4).
 
Event Description
It was reported by the customer, that upon insertion of the intra-aortic balloon (iab) there was difficulty passing through the 8 fr sheath.At that time the iab was removed and re-inserted into a 9 fr sheath however would not inflate.A new iab was utilized and worked successfully.There was no harm or injury to the patient.
 
Event Description
It was reported, by the customer, that upon insertion of the intra-aortic balloon (iab) there was difficulty passing through the 8 fr sheath.At that time the iab was removed and re-inserted into a 9 fr sheath however would not inflate.A new iab was utilized and worked successfully.There was no harm or injury to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MEGA 8FR. 50CC IAB
Type of Device
SYSTEM, 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 Key6741189
MDR Text Key81134982
Report Number2248146-2017-00185
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112327
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 08/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date11/28/2019
Device Catalogue Number0684-00-0497
Device Lot Number3000041330
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2017
Is the Reporter a Health Professional? No
Device AgeYR
Date Manufacturer Received08/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/28/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age65 YR
Patient Weight73
-
-