MAUDE Adverse Event Report: DATASCOPE FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0474

Device Problem Difficult to Remove (1528)

Patient Problem Blood Loss (2597)

Event Date 08/04/2016

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the manufacturer however at this time, it has not been evaluated.When an assessment of the affected product is complete a supplemental report with our additional findings will be provided.(b)(4).

Event Description

While a patient was receiving therapy blood was noticed on the catheter extender tubing; an rn was notified and around 1730 hours more blood was observed.At around 1030 they tried to remove the balloon but were unable to as it appeared stuck in the femerol area.The next day the patient had the balloon removed via vascular surgery.

Manufacturer Narrative

The product was returned with the membrane completely unfolded split open along its length and blood on the interior and exterior of the catheter.An underwater leak test of the catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.We were unable to leak test the membrane due to its returned condition.A visual examination of the membrane, however, did not indicate a leak was present.The evaluation was unable to determine the location of a leak because of the returned condition of the device.The evaluation did indicate dried blood observed was within the iab catheter.This most likely caused the reported removal difficulty event.The evaluation confirms the reported event.(b)(4).

Event Description

While a patient was receiving therapy blood was noticed on the catheter extender tubing; an rn was notified and around 1730 hours more blood was observed.At around 1030 they tried to remove the balloon but were unable to as it appeared stuck in the femoral area.The next day the patient had the balloon removed via vascular surgery.

• Brand Name: LINEAR 7.5 FR. 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: 5905288
• MDR Text Key: 53037194
• Report Number: 2248146-2016-00069
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/16/2018
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000006622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2016
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2015
• 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): Required Intervention
• Patient Age: 55 YR