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

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Ischemia (1942)

Event Date 09/09/2016

Event Type  Injury  

Manufacturer Narrative

The device is not returning to the manufacturer and we will not be able to evaluate the affected product.We continue in our efforts to follow up with the customer, if we obtain additional information we will send a supplemental report with additional findings.(b)(4).

Event Description

Prior to iab insertion and therapy, the patient developed a complication of limb ischemia after having significant and existing history of peripheral vascular disease in bilateral legs.

Manufacturer Narrative

Date received by manufacturer: date was not entered in the initial mdr.Date: received by manufacturer: 09/09/2016.

Event Description

Prior to iab insertion and therapy, the patient developed a complication of limb ischemia after having significant and existing history of peripheral vascular disease in bilateral legs.

• Brand Name: UNKNOWN IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 5998378
• MDR Text Key: 56440883
• Report Number: 2248146-2016-00078
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 09/09/2016
• 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): Life Threatening; Required Intervention