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

Catalog Number 0684-00-0474

Device Problems Inflation Problem (1310); Material Rupture (1546); Device Displays Incorrect Message (2591)

Patient Problems Hematoma (1884); Low Blood Pressure/ Hypotension (1914)

Event Date 08/20/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.(b)(4).

Event Description

The patient presented with a blood pressure of 80/60mmhg and oliguria.It was reported that the patient was taken for an intra-aortic balloon (iab) procedure in cardiac intensive care unit; insertion was done on the right femoral site.After the procedure the patient's vitals were stable and urine output improved.However, 24 hours later balloon was found ruptured.It was reported that the console alarmed 'unable to inflate'.The iab was removed and a new iab was inserted through the left femoral site.The patient did encounter a hematoma at the iab insertion site, but that has subsided.There were no reported injuries to the patient.

• 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: 7865277
• MDR Text Key: 119949624
• Report Number: 2248146-2018-00541
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2021
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000066502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/22/2018
• 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 Age: 70 YR
• Patient Weight: 55