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

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

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.

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.

• Brand Name: INTRA AORTIC BALLOON CATHETER
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 14 philips parkway; montvale NJ 07645
• MDR Report Key: 5594002
• MDR Text Key: 43200326
• Report Number: 2248146-2016-00035
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Nurse
• 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 Received: 04/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 03/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death