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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. SENSATION PLUS; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0568-01U
Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/06/2016
Event Type  malfunction  
Event Description
Under fluoroscopy, a 7.5fr 40cc intra-aortic balloon (iab) catheter was inserted.After insertion it migrated into the iliac artery after being unfurled.The catheter was then difficult to re-wire and advance because it was twisted as well.It was difficult to remove but was removed and an 8fr arrow int'l iab catheter of the same capacity was inserted without issue.Manufacturer response for intra-aortic balloon catheter, sensation plus (per site reporter): they want to analyze it.
 
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Brand Name
SENSATION PLUS
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
15 law dr.
fairfield NJ 07004
MDR Report Key5789776
MDR Text Key49424770
Report Number5789776
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2016
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model Number0684-00-0568-01U
Device Catalogue Number0684-00-0568-01U
Device Lot Number30000230510635
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2016
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/16/2016
Device Age3 MO
Event Location Hospital
Date Report to Manufacturer06/16/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
Patient Age63 YR
Patient Weight79
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