MAUDE Adverse Event Report: ETHICON INC. STLESS STEEL SIL 4X18IN 6 S/A CCS; SUTURE, NONABSORBABLE, STEEL

Catalog Number	M654G
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	11/01/2017
Type of Reportable Event	Serious Injury
Additional 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.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.After how long post-op did the patient experience pain? name, strength and dose of the pain medicine prescribed? any other symptoms noted? patient demographics and medical history were allergy tests completed? results? patient¿s present condition.
Event or Problem Description
It was reported that a patient had a quadruple heart bypass procedure in (b)(6) 2017 and suture was used on the incision.After the procedure, the patient started experiencing pain, radiating across the chest and arms.The patient returned to the doctor and was prescribed pain medication.The patient is still experiencing pain.The patient is currently seeing a specialist for a possible allergy to the alloys in the suture.Additional information has been requested.

• Brand Name: STLESS STEEL SIL 4X18IN 6 S/A CCS
• Common Device Name: SUTURE, NONABSORBABLE, STEEL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7627516
• Report Number: 2210968-2018-73655
• Device Sequence Number: 13908044
• Product Code: GAQ
• UDI-Device Identifier: 10705031000063
• UDI-Public: 10705031000063
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: M654G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention