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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0475
Device Problems Material Rupture (1546); Device Displays Incorrect Message (2591); Device Contamination With Biological Material (2908)
Patient Problem Vascular Dissection (3160)
Event Date 01/21/2017
Event Type  Injury  
Manufacturer Narrative
Ref:(b)(4). Ref: mw5067576 received 15-feb-2017. The product was returned with the membrane completely unfolded and blood on the interior of the exterior of the catheter. The extension tubing was also returned. An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extension tubing was performed and one leak was detected on the membrane at the rear seal 1. 3 cm measuring 0. 013 m in length. The reported problem was most likely triggered by a leak which was found on the membrane. The penetration found on the membrane appears to have been caused by a sharp object. The evaluation confirmed the reported problem. We are unable to determine when this may have occurred.
 
Event Description
Blood observed in the helium tubing. The patient started at durham va medical center and was then transferred to duke medical center with the iab catheter in place. Medwatch form received 02/15/2017 indicating injury: pt with iabp via left femoral artery on 1:1 functioning normally. Approximately 11 hours after initiation, balloon pump began alarming augmentation below set limit and later began alarming multiple things including catheter restriction, and timing issue. Noted small flecks of dark dried blood in helium tubing. Balloon rupture suspected. Device later removed. Intake form received 02/17/2017: left heart cath. Complicated by dissection to mid lad. Stent placement followed. Balloon pump placed for support and dopamine started. Patient to ccu with iabp 1:1, dopamine, propofol,intubated. Overnight lost augmentation and noted blood in iabp tubing.
 
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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 Key6381036
MDR Text Key69167600
Report Number2248146-2017-00015
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
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
Report Date 03/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/05/2019
Device Catalogue Number0684-00-0475
Device Lot Number3000032134
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received02/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/05/2016
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: 03/06/2017 Patient Sequence Number: 1
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