MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY MARKED GUIDEWIRE (2/CS); DILATOR, ESOPHAGEAL

Model Number	000150
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
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.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the 000150, marked guidewire (2/cs), was being used during an egd dilation procedure on (b)(6) 2023 when it was reported, ¿distal spring tip kink after they were pulled out of an endoscope for a dilation procedures that were performed.¿.There was no report of injury, medical intervention, or hospitalization for the patient or user.The procedure was completed with an alternate device causing a 10-minute delay.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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 a total of 4 devices for this lot number and failure mode.(b)(4).This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the 000150, marked guidewire (2/cs), was being used during an egd dilation procedure on (b)(6) 2023 when it was reported, ¿distal spring tip kink after they were pulled out of an endoscope for a dilation procedures that were performed.¿.There was no report of injury, medical intervention, or hospitalization for the patient or user.The procedure was completed with an alternate device causing a 10-minute delay.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: MARKED GUIDEWIRE (2/CS)
• Common Device Name: DILATOR, ESOPHAGEAL
• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 16484575
• Report Number: 3007305485-2023-00047
• Device Sequence Number: 5899374
• Product Code: KNQ
• UDI-Device Identifier: 10653405050858
• UDI-Public: (01)10653405050858(11)221013(10)202210135
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K853274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2023

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
• Operator of Device: Health Professional
• Device Model Number: 000150
• Device Catalogue Number: 000150
• Device Lot Number: 202210135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DIVERSATEK SAFEGUIDE MARKED SPRING TIP GUIDEWIRES; DIVERSATEK SAFEGUIDE MARKED SPRING TIP GUIDEWIRES
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic