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

Model Number 1214-02

Device Problems Material Deformation (2976); Migration (4003)

Patient Problems Perforation of Esophagus (2399); Patient Problem/Medical Problem (2688)

Event Date 10/17/2018

Event Type  Injury  

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 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
• Type of Device: SAFEGUIDE GUIDE WIRE WITH SPRING TIP
• Manufacturer (Section D): DIVERSATEK HEALTHCARE; 102 e keefe ave; milwaukee WI 53212
• Manufacturer (Section G): DIVERSATEK HEALTHCARE; 102 e keefe ave; milwaukee WI 53212
• Manufacturer Contact: laura boll ; 102 e keefe ave; milwaukee, WI 53212 ; 4142657620
• MDR Report Key: 8502004
• MDR Text Key: 141577763
• Report Number: 2183446-2018-00002
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 00816734020975
• UDI-Public: 00816734020975
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K924646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1214-02
• Device Catalogue Number: 1214-02
• Device Lot Number: 214616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: 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
• Date Manufacturer Received: 01/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 41