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

Catalog Number TPW32

Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problems Cardiac Arrest (1762); Ventricular Tachycardia (2132); Palpitations (2467); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.Does the surgeon believe that there was any deficiency in the temporary pacing wire? what is the surgeon opinion as the contributing factor to the migration of the temporary pacing wire? was this case previously reported? (b)(4).

Event Description

It was reported in a journal article that the patient underwent a 3-vessel coronary artery bypass grafting/cabg procedure in 1999 and the epicardial temporary pacing wire was placed.Three years after, in 2002 the patient experienced ventricular tachycardia and presented with respiratory distress that progressed to full cardiopulmonary arrest requiring intubation.Monomorphic ventricular tachycardia was documented at presentation and the patient was successfully cardioverted to sinus rhythm.The patient was extubated the following day.On day 4 of hospitalization, the patient experienced an episode of near syncope associated with palpitations and was transferred for further evaluation.A transesophageal echocardiogram noted a wire passing through the right atrium, right ventricle, and into the pulmonary artery.Fluoroscopy revealed epicardial temporary pacing wires retained from his cabg operation in 1999 and a wire of the same caliber that appeared to course through the right ventricular outflow tract into the pulmonary artery.The intracardiac position and course of the wire were confirmed with a chest computed tomography scan.The unipolar epicardial pacing wire was extracted and non-sustained monomorphic vt occurred during wire manipulation.Because of the patient¿s left ventricular dysfunction, he was still considered to be at high risk for sudden cardiac death and underwent successful defibrillator implantation.The patient has done well, with no palpitations since discharge.Additional information has been requested.

• Brand Name: 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: 6963245
• MDR Text Key: 89794611
• Report Number: 2210968-2017-70609
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Health Professional
• 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: TPW32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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): Hospitalization; Required Intervention
• Patient Age: 66 YR