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

Catalog Number TPW20

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Type  malfunction  

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.Additional information was requested and the following was obtained: was there any change in the patient¿s post-operative course as a result of the partially retained tpw? no.Any adverse patient consequences as a result of the retained tpw? if yes, how was this treated? chest x ray completed to assess foreign body no hemodynamic issues related to suspected retained pacing wire.Are there plans to remove the retained piece? if yes, how and when? no.Did the surgeon observe any deficiency or anomaly of the tpw before, during, after placement? no.What is the surgeon¿s opinion as to the etiology of or contributing factor to the partially retained tpw piece? probably, the fixation suture might trap the wire.But the details are unknown.What is the patient¿s current status? patient¿s status is stable/fine.No unexpected cardiac issues.Has seizures and is being evaluated by neurologist.Here is summary from my last note, (b)(6) 2019: b has a history of tetralogy of fallot (vsd closure, pulmonary valve excision, rvot patch) on (b)(6) 2015.With past testing, 2017, she has trivial pulmonary stenosis.Severe pulmonary regurgitation - no unusual with tetralogy of fallot repair, no good/functional pulmonary valve.No residual vsd shunting.Good heart function.Mild right ventricular dilation - seen with pulmonary regurgitation; this can be tolerated well for many years.What is the lot number of the device that was used? the lot number for pacing wires are not recorded in the patient record, therefore is unavailable.Is the device available for evaluation? no.This event happened in 2015.

Event Description

It was reported that the patient underwent an vsd closure, pulmonary valve excision, rvot patch on (b)(6) 2015 and pacing wire suture was used.The suture broke during removal on (b)(6) 2015.Cxr performed (b)(6) 2015 noted a portion of the wire is retained.An estimated length of 8 to 9 mm in the ap dimension just right lateral to right vertebral edge at level of about t8 in the ap dimension.On lateral view, fragment is about 15 mm from the anterior vertebral body line at about the level of t8.The surgeon reported no apparent deficiencies or anomalies in the suture prior to or during use.The surgeon opined that the contributing factor to the retained piece was ¿probably, the fixation suture might trap the wire.But the details are unknown.¿ the surgeon reported no hemodynamic issues related to suspected retained pacing wire and there are no plans to remove the piece.The patient current status is stable/fine.No unexpected cardiac issues.Has seizures and is being evaluated by neurologist.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: how are you sure this is a broken piece of tpw without removing it? because we knew it was broken when removed.When the site remove the tpw after operation, did they ever note any missing piece? it sometimes happens (trapped wire) and we usually intentionally cut it off.I have never experienced that remaining wire cause adverse events to the patients for my 30-year clinical experience.Is the device still retained in the patient after 4 years? this is not device, just small fiber-like wire.It is a tiny metal, but is not harmful to the patient at all, like metal clips for hemostasis or sternal wires.We have no plan to reopen the patient¿s chest.

• 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: 8593394
• MDR Text Key: 144833841
• Report Number: 2210968-2019-81209
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 10705031050877
• UDI-Public: 10705031050877
• Combination Product (y/n): N
• PMA/PMN Number: K980503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TPW20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2019
• Patient Sequence Number: 1