MAUDE Adverse Event Report: ETHICON INC. TEMP PACING WIRE 24"(60CM) 2-0 BLU; ELECTRODE, PACEMAKER, TEMP

Catalog Number TPW10

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.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.The actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: batch mhb814; batch mhj320.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 date of the initial procedure when the pacing wire was placed? how was the pacing wire used? was an x-ray performed to locate the pacing wire piece? can you describe what tissue was the pacing wire piece retained? can you describe the appearance of the pacing wire piece (size, broken, intact)? does the surgeon plan to remove the pacing wire piece? what is the surgeon¿s opinion as to the potential consequence of pacing wire retained in patient? what are the patient age, gender, weight, medical history? do you have device for evaluation? what is the current condition of the patient?.

Event Description

It was reported that a patient underwent a cardiovascular procedure on an unknown date in (b)(6) 2018 and pacing wire was used.The suture broke and a portion of the pacing wire was retained in the patient.The current status of the patient is unknown.Additional information has been requested.

Manufacturer Narrative

(b)(4).Surgery day and trouble occurrence day (withdrawal date) was (b)(6) 2018.The date is unknown.As of now, there is no plan to remove the product.There is no problem in the patient's condition.Possible lot were mhb814, mhj320.

Manufacturer Narrative

(b)(4).Additional information: the actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: batch mhb814; mfg.Date - 7/7/2018; exp.Date - 6/30/2023 , batch mhj320; mfg.Date - 7/31/2018; exp.Date - 6/30/2023.The device history records were reviewed for the possible batch numbers and the manufacturing criteria was met prior to the release of this lot.Additional information was requested and the following was obtained: what was the date of the initial procedure when the pacing wire was placed? no further information is available.How was the pacing wire used? no further information is available.Was an x-ray performed to locate the pacing wire piece? no further information is available.Can you describe what tissue was the pacing wire piece retained? no further information is available.Can you describe the appearance of the pacing wire piece (size, broken, intact)? no further information is available.Does the surgeon plan to remove the pacing wire piece? as of (b)(6) 2018, there was no plan to remove the product.What is the surgeon¿s opinion as to the potential consequence of pacing wire retained in patient? no further information is available.What are the patient age, gender, weight, medical history? no further information is available.Do you have device for evaluation? no device is available.What is the current condition of the patient? as of (b)(6) 2018, there was no problem in the patient's condition.

• Brand Name: TEMP PACING WIRE 24"(60CM) 2-0 BLU
• Type of Device: ELECTRODE, PACEMAKER, TEMP
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8224211
• MDR Text Key: 132332404
• Report Number: 2210968-2019-78248
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• PMA/PMN Number: K980503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• 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: 01/09/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention