MAUDE Adverse Event Report: BAXTER APATECH LTD; WAX,BONE

Catalog Number 1503832

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Ventricular Fibrillation (2130)

Event Type  Injury  

Manufacturer Narrative

Complaint no: (b)(4).A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient experienced a drop in blood pressure and ventricular fibrillation (vf) during a surgery in which ostene was used.The cause of the drop in blood pressure and the vf was not reported.The indication for the surgery was not reported.It was reported that after applying ostene" the sternal edge, the patient's blood pressure dropped and the patient went into vf".No further detail regarding the surgical technique or the amount of ostene used was provided.As a result, the surgeon opened the patient's pericardium, applied massage by hand, performed defibrillation, and then proceeded to bypass (the medical intervention was not further specified).It was reported that there was no sign of flush to the patient's skin.No further information regarding the patient's outcome was reported.No additional information is available.

• Type of Device: WAX,BONE
• Manufacturer (Section D): BAXTER APATECH LTD; 370 centennial ave; hertfordshire ; UK
• Manufacturer (Section G): BAXTER APATECH LTD; 370 centennial ave; hertfordshire ; UK
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5065069
• MDR Text Key: 25307468
• Report Number: 1416980-2015-35364
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• PMA/PMN Number: K082491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 1503832
• Device Lot Number: ELW55J115BW
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention