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

Catalog Number	DIS150
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A sales representative reported on behalf of her customer that the device, dis150, disposable marked spring tip guidewire, was being used during an egd with dilation procedure on (b)(6) 2023 when the ¿spring tip broke off during a case during intra-op¿.Further assessment revealed that "it fell into the stomach, where the spring tip usually goes", and the "item was retrieved with a retrieval net".The procedure was completed successfully with an alternate like device, and there was a delay of two minutes.There was no reported injury to the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional 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.
Additional 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.A two-year lot history review shows this is the only such occurrence for this lot number and failure mode.(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.Carefully inspect the unit to verify that the sterile package of the product has not been damaged in shipment.Remove the guidewire from packaging and remove the tape attached to wire.Carefully inspect it for any damage that may have occurred during transit or handling.Guidewire is inserted through the biopsy channel of an endoscope with the spring tip to be located just past the esophogastric (e.G.) junction into the gastric cavity.The endoscope is then withdrawn.The guidewire should be monitored externally using markings as dental arch reference points before and during dilatation.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
A sales representative reported on behalf of her customer that the device, dis150, disposable marked spring tip guidewire, was being used during an egd with dilation procedure on (b)(6) 2023 when the ¿spring tip broke off during a case during intra-op¿.Further assessment revealed that "it fell into the stomach, where the spring tip usually goes", and the "item was retrieved with a retrieval net".The procedure was completed successfully with an alternate like device, and there was a delay of two minutes.There was no reported injury to the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: DISPOSABLE MARKED SPRING TIP GUIDEWIRE
• Common Device Name: 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 18230785
• Report Number: 3007305485-2023-00242
• Device Sequence Number: 12145371
• Product Code: OCY
• UDI-Device Identifier: 10653405986553
• UDI-Public: (01)10653405986553(17)250517(10)202305185
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/17/2025
• Device Catalogue Number: DIS150
• Device Lot Number: 202305185
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic