MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0433

Device Problems Occlusion Within Device (1423); Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 08/13/2015

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2015 10:20 am (gmt-4:00) added by (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.

Event Description

During clinical support post cabg the f.O.Sensor became non-functional.Switched to radial art line due to the fact central lumen was also clotted off.Tried unplugging and re-plugging in without success.Attempted to switch to cl for pressure source but it was clotted off.We were able to utilize the radial art line as a pressure source.The catheter to be saved to be evaluated.

• Brand Name: SENSATION 7FR. 34CC IAB
• 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: 5195050
• MDR Text Key: 30067734
• Report Number: 2248146-2015-01036
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• 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: 10/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/01/2018
• Device Catalogue Number: 0684-00-0433
• Device Lot Number: 3000008957
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 10/05/2015
• Initial Date FDA Received: 11/02/2015
• Date Device Manufactured: 05/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR