MAUDE Adverse Event Report: DATASCOPE CORP. LINEAR 7.5FR 40CC IAB; INTRA-AORTIC BALLOON CATHETER

Model Number 0684-00-0475

Device Problems Alarm, audible (1010); Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2014

Event Type  Injury  

Manufacturer Narrative

The device was returned on (b)(4) 2014 and sent to a third party for decontamination.When the device is received back at the manufacturing facility, an eval will be performed and a follow-up report submitted with the results.(b)(4).

Event Description

An iab was placed into a pt with anterial wall mi and hypotension.Suddenly, the iab failed to inflate and the pump alarmed indicating a leak and failure to inflate.Despite all effort (checking valves, connections and changing pump console) the balloon did not inflate and the iab had to be removed prematurely, despite the high risk pt.The pt was saved with great effort and high inotropes.It was reported that a 200 cm non-datascope pressure tubing was added to this device.

• Brand Name: LINEAR 7.5FR 40CC IAB
• Type of Device: INTRA-AORTIC BALLOON CATHETER
• Manufacturer (Section D): DATASCOPE CORP.; fairfield NJ
• Manufacturer Contact: jason souss ; 15 law dr; fairfield, NJ 07004 ; 9737097256
• MDR Report Key: 3784226
• MDR Text Key: 18708459
• Report Number: 2248146-2014-00049
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0684-00-0475
• Device Catalogue Number: 0684-00-0480-XX
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: No
• 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: 69 YR