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

Catalog Number 000150

Device Problem Bent (1059)

Patient Problem Laceration(s) of Esophagus (2398)

Event Date 08/03/2017

Event Type  Injury  

Manufacturer Narrative

The used device and original opened packaging was returned to conmed for evaluation.Visual inspection verified the guidewire had bent/damaged spring tip joint.Based on the evaluation findings, the bend in the device was potentially due to overuse, which causes deterioration of the spring tip joints, or excessive force during use/cleaning.A review of the manufacturing documents has verified the devices were produced according to current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture.A historical review of this device revealed a total of 11 similar reports in which 8 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).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 performing an esophageal dilation with the assistance of a marked guidewire.The procedure of esophageal dilation started with a 27 savary french dilator, then dilated up to size 57 french dilator without major resistance or complication.The patient was then advanced to a size 60 french and dilated without resistance; however on removal of the guidewire and dilator, there was blood on the distal tip of the dilator and the guidewire tip was bent.Rigid esophagoscopy was performed to evaluate the esophagus.Patient had a mild tear of the posterior mucosa esophageal wall.There was no tear/penetration through the underlying muscle.No further interventions were needed.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. alejandro dumas no. 11321; complejo industrial chihuahua; chihuahua, CP 11 36; MX CP 1136
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer Contact: martha camacho urribarri ; 525 french road; utica, NY 13502-5994
• MDR Report Key: 6818621
• MDR Text Key: 83603236
• Report Number: 3007305485-2017-00186
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 00653405050851
• UDI-Public: (01)00653405050851(30)1(10)201603044
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 000150
• Device Lot Number: 201603044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 54