MAUDE Adverse Event Report: ETHICON INC. TEMPORARY PACING WIRE; ELECTRODE, PACEMAKER, TEMP

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Blood Loss (2597); No Code Available (3191)

Event Date 04/17/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).Date sent to the fda : 05/26/2016.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information: the actual device product code associated with this event is not known.The international affiliate reports the following possible product codes: ep15, tpw10.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What was the specific placement location and number of pacing wires used on patient? did the patient have any myocardial ischemia? were the wires placed in potentially ischemic tissue? how were the wires positioned/ placed? method and timing of placement (atrial and/or ventricular, anatomic position, unipolar vs bipolar, intramyocardial vs epicardial, method of securing in position).How did the surgeon attempt to remove the pacing wires? was hemostasis achieved after the wires were removed? when did the patient present with symptoms (hours post op)? what testing was performed to identify the location of the bleeding? can you describe the appearance of the area during second procedure? what was performed / intervention to stop the bleeding? what tissue was the bleeding coming from? what was the cause of death? was an autopsy performed? what are the patient demographics (initials, age, wt, medical conditions)? clinical history (especially history of recent myocardial infarction) what is the surgeon¿s opinion as to the relationship of the wires to the cause of death?.

Event Description

It was reported that a patient underwent a revascularization of the myocardium, a heart surgery, on (b)(6) 2016 and a temporary pacing wire was used.Removal of the pacemaker thread, after the myocardial revascularization surgery, may have caused bleeding that led to the patient's death.An exploratory thoracotomy was performed to investigate the cause of bleeding.Additional information has been requested.

Manufacturer Narrative

The nurse who reported the complaint stated that one doctor of the team suggested that the thread removing in the post-surgical of revascularization may have caused the bleeding.The revascularization occurred on (b)(6) 2016 and exploratory thoracotomy occurred on (b)(6) 2016 to investigate the bleeding and repair, but on the same day the patient died.

• Brand Name: TEMPORARY PACING WIRE
• Type of Device: ELECTRODE, PACEMAKER, TEMP
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): UNKNOWN; unknown; x
• Manufacturer Contact: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 5682100
• MDR Text Key: 46004737
• Report Number: 2210968-2016-09259
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K980503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2016
• 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): Death; Required Intervention