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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. INTRA AORTIC BALLOON CATHETER SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. INTRA AORTIC BALLOON CATHETER SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Congestive Heart Failure (1783); Death (1802); Ischemia (1942); Multiple Organ Failure (3261)
Event Type  Death  
Manufacturer Narrative
Date received by mfr: 03/24/2016.
 
Event Description
(b)(6), rn told me back in december that they had a patient who received an iab and subsequently acquired limb ischemia, a week later the foot was amputated. The patient had severe chf and multi-system failure when he died several weeks later. She stated the death was not related to the iab. I¿m awaiting further information from the clinical nurse specialists on the unit.
 
Manufacturer Narrative
It's confirmed that the device will not be returned to the manufacturer and we're unable to complete an evaluation on the affected product we continue in our efforts to follow up with the customer for additional information; we will send a supplemental report with any collected additional findings. (b)(4).
 
Event Description
(b)(6), rn told me back in (b)(6) that they had a patient who received an iab and subsequently acquired limb ischemia, a week later the foot was amputated. The patient had severe chf and multi-system failure when he died several weeks later. She stated the death was not related to the iab. I'm awaiting further information from the clinical nurse specialists on the unit.
 
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Brand NameINTRA AORTIC BALLOON CATHETER
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
14 philips parkway
montvale NJ 07645
MDR Report Key5594002
MDR Text Key105959384
Report Number2248146-2016-00035
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received03/24/2016
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: 04/21/2016 Patient Sequence Number: 1
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