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

Catalog Number 0684-00-0497

Device Problems Kinked (1339); Failure to Advance (2524)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 12/12/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not yet been returned to maquet for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.Lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.(b)(4).

Event Description

Doctor removed a 6 fr pinnacle from groan after pci.Tried to place 1st 8 fr iab sheath.He could not get the sheath to advance and it "kinked" on him.Opened a 2nd iab insertion kit.Was able to gain access but there was significant bleed around the sheath.A hematoma developed, so they went to the opposite side with a 9 fr terumo sheath and successfully placed the balloon.Staff had to hold pressure for 2hrs.

• 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: 5347652
• MDR Text Key: 35164057
• Report Number: 2248146-2016-00004
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/22/2018
• Device Catalogue Number: 0684-00-0497
• Device Lot Number: 3000016196
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2015
• Date Device Manufactured: 09/22/2015
• 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): Hospitalization; Required Intervention