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

Model Number LINEAR 7.5 FR. 40CC IAB

Device Problem Insufficient Information (3190)

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

Event Date 07/31/2015

Event Type  Injury  

Manufacturer Narrative

August 25, 2015 07:13 pm (gmt-4:00) added by (b)(6): the device has not yet been returned to maquet cardiac surgery 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.

Event Description

During clinical support with a linear 7.5 fr 40cc balloon and cardiosave/hybrid console bleeding was occuring at insertion site.A femstop device was applied to attempt to control bleeding because of large hemotoma developing.Catheter restriction occured femstop removed with hand pressure applied at this time.Catheter restriction still after removal (possible kink at site of femstop).

Manufacturer Narrative

(b)(4).The evaluation method code was changed from "actual product evaluated" to "actual product not evaluated".

Event Description

During clinical support with a linear 7.5 fr 40cc balloon and cardiosave/hybrid console bleeding was occuring at insertion site.A femstop device was applied to attempt to control bleeding because of large hemotoma developing.Catheter restriction occured femstop removed with hand pressure applied at this time.Catheter restriction still after removal (possible kink at site of femstop).

Manufacturer Narrative

10/30/2015 02:56 pm (gmt-4:00) added by (b)(4): the serial number provided by the customer was incorrect and is now unavailable when we tried to clarify the serial number of the device.

Event Description

During clinical support with a linear 7.5 fr 40cc balloon and cardiosave/hybrid console bleeding was occuring at insertion site.A femstop device was applied to attempt to control bleeding because of large hemotoma developing.Catheter restriction occured femstop removed with hand pressure applied at this time.Catheter restriction still after removal (possible kink at site of femstop).

• Brand Name: INTRA AORTIC BALLOON
• 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: 5033644
• MDR Text Key: 24191493
• Report Number: 2248146-2015-01004
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Followup,Followup
• Report Date: 07/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2017
• Device Model Number: LINEAR 7.5 FR. 40CC IAB
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: LINEAR 7.5 FR. 40CC IAB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 10/28/2015
• Date Device Manufactured: 12/15/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR