MAUDE Adverse Event Report: MEDICAL CONCEPTS EUROPE BM BI-POLAR TEMPORARY PACING WIRE; ELECTRODE, PACEMAKER, TEMPORARY

Catalog Number BM608ABBG

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/19/2016

Event Type  malfunction  

Event Description

Patient underwent coronary artery bypass grafting (cabg) in late (b)(6), 2014.He had temporary epicardial pacing wires placed at the time of surgery.The patient was discharged from the hospital six days after surgery.He had follow up clinic visit a month later and was doing well at that time per progress note.The epicardial pacing wires were cut prior to discharge leaving a portion of the wire internal.The practice for pulling wires vs.Cutting wires is surgeon dependent and patient dependent.This practice varies across the country and per hospital policy.At times the risk of pulling wires poses greater risk to the patient than leaving wires.Cv surgeon was notified by outside provider that recent radiology study showed a foreign body which appeared to be a wire in the patient's pulmonary artery.The interventional radiologist was able to retrieve the foreign body from the patient.The foreign body appeared to be a pacing wire.The wire would have had to migrate from epicardial space through the myocardium and into the heart to the pulmonary artery.The cardiologist can find no reported cases in the literature and requested this event be reported to the fda.The pacing wire was taken to pathology and is stored.Unfortunately i was just made aware of this event and issue.The wire has been secured in our pathology department since january.

• Brand Name: BM BI-POLAR TEMPORARY PACING WIRE
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): MEDICAL CONCEPTS EUROPE; jennifer hadfield; 1 boston pl. ste 2600; boston MA 02108
• MDR Report Key: 6099430
• MDR Text Key: 59771249
• Report Number: 6099430
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: BM608ABBG
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR