MAUDE Adverse Event Report: COVIDIEN SS FLEX/TEF OR1X24T5/CS6 2/0DA; PACING WIRE

Model Number 8886261753

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/25/2014

Event Type  Injury  

Event Description

Procedure type: cardiac.According to the reporter: circular portion of pacing wire broke off in chest cavity.An x-ray was taken and confirmed that needle was located in chest.Provider searched for needle for approximately 45 minutes but was unable to locate it.Since needle was in an area that would not produce any damage, decision was made to let needle remain in patient.(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: SS FLEX/TEF OR1X24T5/CS6 2/0DA
• Type of Device: PACING WIRE
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer (Section G): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4168483
• MDR Text Key: 4872694
• Report Number: 9612501-2014-00337
• 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: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8886261753
• Device Catalogue Number: 8886261753
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other