MAUDE Adverse Event Report: ETHICON INC. TEMPORARY CARDIAC PACING WIRE; ELECTRODE, PACEMAKER, TEMP

Catalog Number TPW20

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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 operating surgeon observe any suture deficiency or anomaly before, during or after its use in the patient? no did any piece of the needle fall inside of the patient? if so, was the needle piece removed and how? no, it was hold by holder.Proper analysis can not be performed with supplied photo.

Event Description

It was reported that the patient underwent heart bypass surgery and pacing wire was used.The needle pulled off from the suture during use, as pacing a lead.A like device was used to complete the procedure.There were no adverse consequences for the patient reported.

Manufacturer Narrative

The used needle pieces were examined for visual inspection attribute defects and no defects were observed.The hole of the needles was examined for suture remnant and no remnant was found in the hole.Force or technique used that could cause premature suture/needle separation cannot be determined.

• Brand Name: TEMPORARY CARDIAC PACING WIRE
• Type of Device: ELECTRODE, PACEMAKER, TEMP
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 6041894
• MDR Text Key: 57927531
• Report Number: 2210968-2016-14436
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K980503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: TPW20
• Device Lot Number: KBP679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2016
• 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