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

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Renal Failure (2041)

Event Type  Death  

Manufacturer Narrative

There was no reported device malfunction however the device was to be returned as per the customer.The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.We continue our efforts to follow up with the customer for its return.(b)(4).

Event Description

It was reported that a patient required intra-aortic balloon (iab) cardiac assistance due to a mi.The iab was inserted under fluoroscopy.The patient's troponin levels dropped.The patient was then scheduled for surgery and placed on heparin infusion as per ward protocol.Six days post-insertion it was discovered that the patient had a retro-peritoneal bleed from the opposite groin to the iab and was bleeding out.The heparin was then stopped.The retro-peritoneal bleed was monitored.The patient then suffered renal failure and expired.The date of expiration is unknown.There was no reported malfunction of the iab.The facility does not attribute the death to the device.

• Brand Name: UNKNOWN
• 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 Key: 6855990
• MDR Text Key: 85736529
• Report Number: 2248146-2017-00383
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 08/21/2017
• 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