MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY MARKED GUIDEWIRE; MARKED SPRING TIP GUIDEWIRE

Catalog Number 000150

Device Problem Bent (1059)

Patient Problem Perforation of Esophagus (2399)

Event Date 07/26/2017

Event Type  Injury  

Manufacturer Narrative

The used device without its original packaging was returned to conmed for evaluation.Visual inspection verified the guidewire was bent.The device was observed to have two bends on the spring tip and one bend in the metal wire component.The braided wire component of the snare, that was used to remove the guidewire, was attached to the distal bend.Based on the evaluation findings, the bend in the device was most likely due to overuse, which causes deterioration of the spring tip joints, or excessive force during use/cleaning.A review of the manufacturing documents was unable to be performed as the lot number was not provided by the user facility.A historical review of this device revealed a total of 10 similar reports in which 6 have been verified in the past two years.In that same timeframe, (b)(4) units have been sold worldwide, making the rate of occurrence of this confirmed failure (b)(4) percent.A risk analysis was performed and based on the clinical data report, the undesirable side effects, under normal conditions of use, are acceptable when weighed against the benefits to patient.The instructions for use advise the user of the following.Carefully inspect the guidewire after each use.Inspect the flexible spring tip and discard the wire if the tip appears to be bent or fatigued.Inspect the soldered joints and discard the wire if the soldered joints appear discolored, loose or cracked.Avoid using excessive force on the wire and spring top while cleaning.Do not bend or twist the spring tip as it may cause the soldered joints to deteriorate.Since the marked guidewire is a reusable device that is subject to varied use and cleaning environments, the life span of the product cannot be guaranteed.Due to the severity of this reported patient injury, an investigation has been initiated.

Event Description

A physician was preforming an esophageal dilation with an american dilator and a marked guidewire.After the second dilator was passed down, the wire bent and perforated the wall of the esophagus.A snare was then used to remove it.Additional information has since been collected about the patient and event.After the perforation occurred, the patient was intubated and stabilized before being transported to the er.A cardio thoracic surgeon assessed the ct scan and determined the small visualized tear would heal on its own; therefore, no further intervention was necessary.To date, the patient has been moved to a rehabilitation unit and is being monitored.A small leak caused by the tear is still present and will be re-evaluated in 2-3 weeks.The thoracic surgeon is still confident this tear will heal on its own but the re-evaluation will help determine this.This report is raised on the basis of a reported patient injury.

• Brand Name: MARKED GUIDEWIRE
• Type of Device: MARKED SPRING TIP GUIDEWIRE
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandra dumas no. 11321; complejo inductrial chihuahua; chihuahua, mexica 31136 ; MX 31136
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer Contact: lindsey sheppard ; 525 french road; utica, NY 13502-5994 ; 7273995209
• MDR Report Key: 6803711
• MDR Text Key: 83032040
• Report Number: 3007305485-2017-00180
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K853274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 000150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 82 YR
• Patient Weight: 59