MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY DISPOSABLE MARKED SPRING TIP GUIDEWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number DIS150

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problems Perforation of Esophagus (2399); Device Embedded In Tissue or Plaque (3165)

Event Date 01/25/2022

Event Type  Injury  

Event Description

This complaint was created due to the receipt of a medwatch report (mw5107202) on 8mar22.The current complaint database has been researched for this event and there were no findings.The report was found to be written against dis150, disposable marked spring tip guidewire, that was being used during a egd with esophageal dilation and botox injection that occurred on (b)(6) 2022.The report stated ¿patient having esophageal dilation for diffuse esophageal spasms.During dilations the guidewire for dilation became embedded in esophagus, a tear occurred in the distal esophagus which was repaired with an ovesco clip.The guidewires may appear easier to kink with manipulation.Also.A perforation of the upper esophageal sphincter occurred which required a left cervical neck exploration/drainage and peg tub placement.¿.Further assessment questioning found that after the last dilation, the guidewire and the dilator were attempted to be withdrawn but met resistance when attempting to pull out the guidewire.So, the guidewire was kept in place.Relook with the scope revealed that the distal tip of the guidewire was kinked/coiled with the loop embedded in the esophageal mucosa.Multiple attempts to detach the guidewire loop from the esophageal mucosa were made and ultimately detachment was successful using rat tooth forceps and pulling the entire guidewire into the stomach.3 cm vertical tear visualized where the guidewire had previously embedded.The guidewire after removal did appear to have a kink, this time in middle aspect, likely creating resistance in the ues and oral cavity.Initially the perforation was clipped and then the patient had cervical exploration, egd and feeding tube placement.The patient was intubated and placed in icu.The patient had 9 days admission total.Current status of patient is listed as ¿stable¿.This report is being raised on the basis of injury due to a report of tear in the distal esophagus causing intubation and icu admittance.

Manufacturer Narrative

The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Manufacturer Narrative

The device is not being returned and no photograph evidence was provided.Therefore, the reported failure could not be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of (b)(4) complaints, regarding (b)(4) devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised that the guidewire should not be advanced if resistance is met without determining the cause and taking remedial action.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

This complaint was created due to the receipt of a medwatch report (mw5107202) on (b)(6) 2022.The current complaint database has been researched for this event and there were no findings.The report was found to be written against dis150, disposable marked spring tip guidewire, that was being used during a egd with esophageal dilation and botox injection that occurred on (b)(6) 2022.The report stated ¿patient having esophageal dilation for diffuse esophageal spasms.During dilations the guidewire for dilation became embedded in esophagus, a tear occurred in the distal esophagus which was repaired with an ovesco clip.The guidewires may appear easier to kink with manipulation.Also.A perforation of the upper esophageal sphincter occurred which required a left cervical neck exploration/drainage and peg tub placement.¿.Further assessment questioning found that after the last dilation, the guidewire and the dilator were attempted to be withdrawn but met resistance when attempting to pull out the guidewire.So, the guidewire was kept in place.Relook with the scope revealed that the distal tip of the guidewire was kinked/coiled with the loop embedded in the esophageal mucosa.Multiple attempts to detach the guidewire loop from the esophageal mucosa were made and ultimately detachment was successful using rat tooth forceps and pulling the entire guidewire into the stomach.3 cm vertical tear visualized where the guidewire had previously embedded.The guidewire after removal did appear to have a kink, this time in middle aspect, likely creating resistance in the ues and oral cavity.Initially the perforation was clipped and then the patient had cervical exploration, egd and feeding tube placement.The patient was intubated and placed in icu.The patient had 9 days admission total.Current status of patient is listed as ¿stable¿.This report is being raised on the basis of injury due to a report of tear in the distal esophagus causing intubation and icu admittance.

• Brand Name: DISPOSABLE MARKED SPRING TIP GUIDEWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 13955717
• MDR Text Key: 290562635
• Report Number: 3007305485-2022-00040
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10653405986553
• UDI-Public: (01)10653405986553(17)231207(10)202112075
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 05/03/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2023
• Device Model Number: DIS150
• Device Catalogue Number: DIS150
• Device Lot Number: 202112075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 03/30/2022
• Supplement Dates Manufacturer Received: 04/06/2022
• Supplement Dates FDA Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: RAT TOOTH FORCEPS.; RAT TOOTH FORCEPS.
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic