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

Catalog Number TPW10

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hemorrhage/Bleeding (1888); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.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.Does the surgeon believe that there was any deficiency in the temporary pacing wire? does the surgeon believe the major bleeding was related to the temporary pacing device? how much blood loss was noted in ml? was the patient provided with transfusion? were these cases previously reported?.

Event Description

It was reported in a journal article that a patient underwent a coronary artery bypass surgery (cabg) between january 2007 and june 2009 and a temporary pacing wire was inserted for prevention of atrial fibrillation (af).The patient received biatrial overdrive pacing and oral metoprolol (50¿150mg) daily for 72 hours after cabg starting immediately after the surgery.The temporary biatrial pacing wire was implanted during the operation.The patient possibly experienced atrial fibrillation and developed major bleeding from the left atrium caused by the implantation of the left atrial pacing wire.The bleeding site was sutured successfully and caused no morbidity.Additional information was requested.

• Brand Name: ETHICON TEMPORARY PACING WIRE
• Type of Device: ELECTRODE, PACEMAKER, TEMP
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 6962934
• MDR Text Key: 89793283
• Report Number: 2210968-2017-70593
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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
• Report Date: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TPW10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2017
• 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): Required Intervention