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

Model Number DIS150

Device Problem Material Fragmentation (1261)

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

Event Date 11/17/2022

Event Type  malfunction  

Event Description

The sales representative reported on behalf of the customer that the dis150, disposable marked spring tip guidewire, was used during an esophagogastroduodenoscopy procedure on (b)(6) 2022 when it was reported, ¿during an esophageal otw dilation, dis150 guidewire broke off near the start of the spring tip.It was successfully removed with rat tooth forceps.¿ after a further assessment, it was reported,¿ a portion of the guidewire broke off and was in the esophagus¿.After removing the device with rat tooth forceps, the procedure was completed and had no patient or user impact.The patient did not require surgical intervention or an extended stay at the hospital.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

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.This issue will continue to be monitored through the complaint system to assure patient safety.Conmed has not received the device.

Manufacturer Narrative

Reported event of the guidewire being broken is confirmed.Received two dis150 in original package.Lot number was verified.Performed a visual inspection, the guidewire was broken/dissembled from the product.A device history record review found no abnormalities that would contribute to this reported event.A two-year lot history review was conducted and found no similar events reported for this lot number.A two-year review of complaint history revealed there has been a total of 15 reports, regarding 24 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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the dis150, disposable marked spring tip guidewire, was used during an esophagogastroduodenoscopy procedure on (b)(6) 2022 when it was reported, ¿during an esophageal otw dilation, dis150 guidewire broke off near the start of the spring tip.It was successfully removed with rat tooth forceps.¿.After a further assessment, it was reported,¿ a portion of the guidewire broke off and was in the esophagus¿.After removing the device with rat tooth forceps, the procedure was completed and had no patient or user impact.The patient did not require surgical intervention or an extended stay at the hospital.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• 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: aubrey nardozzi ; 11311 concept blvd; largo, FL 33773 ; 7273995288
• MDR Report Key: 15932608
• MDR Text Key: 306110167
• Report Number: 3007305485-2022-00182
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10653405986553
• UDI-Public: (01)10653405986553(17)240803(10)202208044
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

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 Model Number: DIS150
• Device Catalogue Number: DIS150
• Device Lot Number: 202208044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/07/2022
• Supplement Dates Manufacturer Received: 12/22/2022
• Supplement Dates FDA Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2022
• 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
• Patient Ethnicity: Non Hispanic