MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY CLEANGUIDE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY, PRODUCT CODE: OCY

Catalog Number	DIS150
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This complaint was created due to the receipt of a medsun report ((b)(4)) received on 19may25.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,1.86 mm x 210 cm.This was reported as a product problem not an adverse event.The report states that in (b)(6) 2025, the device was used in an esophagogastroduodenoscopy with biopsy, single or multiple procedure, and ¿the wire device itself was broken at about an 80- or 90-degree angle from normal".Further assessment found that "broken" meant the device was bent.The device did not fragment or fall into the surgical site.The procedure was completed as normal, without the use of an alternate device and with no delay.There was no injury, medical/surgical intervention or extended hospitalization required for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
This complaint was created due to the receipt of a medsun report (b)(4) received on 19may25.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,1.86 mm x 210 cm.This was reported as a product.Problem not an adverse event.The report states that in apr-2025, the device was used in a esophagogastroduodenoscopy with biopsy, single or multiple procedure, and "the wire device itself was broken at about an 80- or 90-degree angle from normal.".Further assessment found that "broken" meant the device was bent.The device did not fragment or fall into the surgical site.The procedure was completed as normal, without the use of an alternate device and with no delay.There was no injury, medical/surgical intervention or extended hospitalization required for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Response to fda request: report number added to block h.10.Examination of the returned used device dis150 found that part of the spring was bent.It is still attached to the device, but the spring is bent.Root cause cannot be determined, however, based upon ifu; a possible cause of this event could be that resistance was met while advancing the guidewire.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.A two-year lot history review shows a total of 1 device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of five reports, regarding 14 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 the following: the guidewire should not be advanced if resistance is met without determining the cause and taking remedial action.Carefully inspect the unit to verify that the sterile package of the product has not been damaged in shipment.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: CLEANGUIDE
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY, PRODUCT CODE: OCY
• 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 22114248
• Report Number: 3007305485-2025-00093
• Device Sequence Number: 11824993
• Product Code: OCY
• UDI-Device Identifier: 10653405986553
• UDI-Public: (01)10653405986553(17)260528(10)202405284
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2026
• Device Catalogue Number: DIS150
• Device Lot Number: 202405284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic