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

Catalog Number DIS150

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2023

Event Type  malfunction  

Event Description

This complaint was created due to the receipt of a medwatch report mw5148307 on 15dec23.The report was found to be written against dis150, disposable marked spring tip guidewire, that was being used during an unknown procedure on (b)(6) 2023.The report stated, ¿a guidewire was introduced into the patient's stomach in order to utilize for a subsequent dilation of the esophagus.The majority of the tip of the wire broke off into the patient's stomach.Luckily, the md was able to retrieve and remove it from the patient's stomach.¿.The procedure was completed and there was no report of medical intervention or extended hospitalization for the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

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.

Event Description

This complaint was created due to the receipt of a medwatch report mw5148307 on 15dec23.The report was found to be written against dis150, disposable marked spring tip guidewire, that was being used during an unknown procedure on (b)(6) 2023.The report stated, "a guidewire was introduced into the patient's stomach in order to utilize for a subsequent dilation of the esophagus.The majority of the tip of the wire broke off into the patient's stomach.Luckily, the md was able to retrieve and remove it from the patient's stomach." the procedure was completed and there was no report of medical intervention or extended hospitalization for the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

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 that safe and effective electrosurgery is dependent not only on equipment design, but also on factors under the control of the operator.It is important that the instructions supplied with this equipment be read, understood and followed in order to ensure safe and effective use of the equipment.We will continue to monitor for trends through the complaint system to assure patient safety.

• 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 18474006
• MDR Text Key: 332994174
• Report Number: 3007305485-2024-00004
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DIS150
• Device Lot Number: 202310104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 01/30/2024
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2023
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic