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

Catalog Number	TPW30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2018
Type of Reportable Event	Malfunction
Additional 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.Additional information was requested: did a piece of the needle fall into the patient? if yes, was the needle piece removed, and how? were x-rays taken to locate the needle piece(s)? was the patient brought back to or to have needle removed or was the needle removed during the initial procedure? was there any additional tissue damage as a result of searching for the needle piece? what was the size of the needle used? what was the size of the needle that broke off into the patient? was more than half the needle retained in the patient? the following information was obtained: no needle fall into the patient and didn't required any other treatment.
Event or Problem Description
It was reported that a patient underwent a cabg and mitral valve replacement procedures on (b)(6) 2018 and pacing wire was used.During the procedure, the pacing wire needle broke.There were no adverse patient consequences reported.The needle did not fall into the patient and the patient did not require further treatment.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: (b)(4) 2018.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.
Additional Manufacturer Narrative
Pc-(b)(4).As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.

• Brand Name: TEMP PACING WIRE 24"(60CM) 2-0 BLU
• Common Device Name: ELECTRODE, PACEMAKER, TEMP
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7282827
• Report Number: 2210968-2018-70934
• Device Sequence Number: 18862677
• Product Code: LDF
• UDI-Device Identifier: 10705031050884
• UDI-Public: 10705031050884
• Combination Product (Y/N): N
• PMA/510(K) Number: K980503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: TPW30
• Device Lot Number: LJJ769
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2018
• Supplement Date Received by Manufacturer: 02/03/2018; 03/23/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 03/07/2018; 04/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1