MAUDE Adverse Event Report: DIVERSATEK HEALTHCARE MEDOVATIONS; SAFEGUIDE GUIDE WIRE WITH SPRING TIP

Model Number	1214-02
Medical Device Problem Codes	Material Deformation (2976); Migration (4003)
Health Effect - Clinical Codes	Perforation of Esophagus (2399); Patient Problem/Medical Problem (2688)
Date of Event	10/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported an esophageal perforation and repair through thoracic surgery.The device was not returned for evaluation by the manufacturer.However, the device history record of the manufacturing lot was reviewed and no issues were recorded.The manufacturer also reviewed complaint trending reports.No similar issues have been reported in any complaint trends.Therefore, the manufacturer believes this to be an isolated incident related to use of the device.This is a reusable device that was approximately 4-1/2 years old.The instructions for use state "visually inspect the guidewire for signs of wear or degradation such as kinks, bends, or break.Worn guidewires should not be used as they may not perform as expected".Kinked or worn devices will kink more easily during use.Additionally, perforations are a known contraindication for esophageal procedures.The instructions for use state: "contraindications include those specific to upper gi endoscopy.Contraindications to dilation include, but are not limited to: uncooperative patient; asymptomatic strictures; inability to advance the dilator through the strictured area; coagulopathy; known or suspected perforation; severe inflammation or scarring near the dilation site, recent myocardial infarction, active ulcer and severe cervical arthritis".The device design and manufacturing is not believed to have caused or contributed to the adverse event.(b)(4) has determined that there are no new safety or efficacy issues as a result of this event and therefore, no further action will be taken.
Event or Problem Description
During an esophagogastroduodenoscopy savory dilatroes with guide-wire was used.Guide-wire could not be removed.Imaging studies revealed guide wire kinked outside of esophagus with small pneumothorax.Patient transferred to a higher level of care facility.Cardiothoracic surgery performed to extract the wire.

• Brand Name: MEDOVATIONS
• Common Device Name: SAFEGUIDE GUIDE WIRE WITH SPRING TIP
• Manufacturer (Section D): DIVERSATEK HEALTHCARE; 102 e keefe ave; milwaukee WI 53212
• MDR Report Key: 8502004
• Report Number: 2183446-2018-00002
• Device Sequence Number: 14157345
• Product Code: KNQ
• UDI-Device Identifier: 00816734020975
• UDI-Public: 00816734020975
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K924646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/01/2019
• Report Date (Section F): 01/01/2019

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: No Information
• Device Model Number: 1214-02
• Device Catalogue Number: 1214-02
• Device Lot Number: 214616
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/17/2018
• Device Age: 54 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/01/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/01/2019
• Initial Report FDA Received Date: 04/10/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 41