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

Model Number DIS150

Device Problem Material Twisted/Bent (2981)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/22/2022

Event Type  Injury  

Event Description

This complaint was created due to the receipt of a medsun report (2200710000-2022-8035) received on (b)(6) 2023.A search of the complaint system has not found a complaint reported for this device/lot number during this timeframe.The report was found to be written against the dis150, disposable marked spring tip guidewire.The report states that on (b)(6) 2022 ¿savary wire was used for esophageal dilation.The distal end of the wire kinked/ bent leaving a jagged edge ultimately injuring the distal esophageal mucosa and ge junction.The wire was removed from the patient and bagged with the original packaging.There was injury or impact to the patient or user.Per the surgeon¿s op notes, ¿the ge junction was at 45cm from the incisors, and we noticed that the spring-loaded guidewire had kink at the junction where the wire meets a spring load component.This created a sharp edge and appeared to create some mucosal injury at the ge junction.We saw some mucosa that was lifted up in a small area.The surgeon did not think there was any full-thickness injury.There was a little bit of bleeding.The surgeon scoped carefully around this area and then entered the stomach, which had no injury.We performed a retroflexed view of the underside of the ge junction, which had no injury and no mucosal tear." this report is being raised due to the reported injury of mucosal lifted up in a small area.

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.We will continue to monitor for trends through the complaint system to assure patient safety.

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot 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.(b)(4).Per the instructions for use, the user is advised the following: the guidewire should not be advanced if resistance is met without determining the cause and taking remedial action.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

This complaint was created due to the receipt of a medsun report ((b)(4)) received on 12may23.A search of the complaint system has not found a complaint reported for this device/lot number during this timeframe.The report was found to be written against the dis150, disposable marked spring tip guidewire.The report states that on (b)(6) 2022 ¿savary wire was used for esophageal dilation.The distal end of the wire kinked/ bent leaving a jagged edge ultimately injuring the distal esophageal mucosa and ge junction.The wire was removed from the patient and bagged with the original packaging.There was injury or impact to the patient or user.Per the surgeon¿s op notes, ¿the ge junction was at 45cm from the incisors, and we noticed that the spring-loaded guidewire had kink at the junction where the wire meets a spring load component.This created a sharp edge and appeared to create some mucosal injury at the ge junction.We saw some mucosa that was lifted up in a small area.The surgeon did not think there was any full-thickness injury.There was a little bit of bleeding.The surgeon scoped carefully around this area and then entered the stomach, which had no injury.We performed a retroflexed view of the underside of the ge junction, which had no injury and no mucosal tear." this report is being raised due to the reported injury of mucosal lifted up in a small area.

• 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: robin drum ; 11311 concept blvd.; largo, FL 33773 ; 8653881978
• MDR Report Key: 17051562
• MDR Text Key: 316479418
• Report Number: 3007305485-2023-00138
• Device Sequence Number: 1
• Product Code: OCY
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/07/2023

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: 01/05/2024
• Device Model Number: DIS150
• Device Catalogue Number: DIS150
• Device Lot Number: 202201054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 06/02/2023
• Supplement Dates Manufacturer Received: 06/13/2023
• Supplement Dates FDA Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic