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 No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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.Additional information was requested and the following was obtained: did the pacing wire break post-operatively? they believe so yes.How was it confirmed that the pacing wire was broken? the pacing machine was alarming saying it couldn't pace.Was there any medical/surgical intervention done to address the broken pacing wire? they just replaced with a new wire.No surgical intervention needed.Was the new pacing wire on standby to fit inserted on the patient in a separate procedure to address the broken pacing wire? no additional procedure needed.Any device available to return for evaluation? yes but its with smtl in wales for testing at the moment.

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date and a temporary pacing wire was used.The wire frayed whilst in situ.The pacing wire broke on the blue insulated wire.It happened at some point between arrival in itu and moved into hdu.It was noted that the pacing machine was alarming saying unable to pace.They had a new pacing wire on standby to fit.No adverse outcome to patient.No extra procedure required.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional evaluation summary: it was received for analysis two needle-suture pieces and a suture piece of product code tpw10.During the visual inspection of the dispensed samples, the swage and attachment area of needles were as expected; however damage on the coated of polyethylene from strand was observed and the ends were cut.Due to condition of the samples received no functional test could be performed.The assignable cause suggests an improper handling of the sample.

• 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: 8460563
• MDR Text Key: 140628738
• Report Number: 2210968-2019-79765
• 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: foreign,other
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TPW10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/28/2019
• Supplement Dates Manufacturer Received: 03/01/2019
• Supplement Dates FDA Received: 05/07/2019
• Patient Sequence Number: 1