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

Model Number DIS150

Device Problem Break (1069)

Patient Problem Laceration(s) of Esophagus (2398)

Event Date 02/28/2023

Event Type  Injury  

Event Description

The sales representative reported on behalf of the customer that the dis150 disposable marked spring tip guidewire was being used on (b)(6) 2023 during a rigid esophageal dilation and the ¿spring tip snapped during procedure and cut patients' esophagus¿.There was a small cut to patient¿s esophagus / discomfort after the procedure.After further assessment it was found that the procedure was not completed, "the patient's esophagus perforated from the wire breaking at the spring tip".The dis150 was utilized as a guide for a rigid dilator - used normally at the time of the event.This was the first use of the dis150.The perforation required x-tack suturing.There was a delay to the procedure, the sales representative stated, ¿i am unsure of the length, but management of the perforation added time to the procedure.¿ the patient initially felt slight discomfort post-procedure.The sales representative stated, ¿i have not heard anything from the hospital so i would assume the patient is fine.The patient stayed longer than normal post-procedure - i am unsure the exact length of time.The patient was able to return home that day.".This report is being raised on the basis of injury due to cut to esophagus.

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 for trends through the complaint system to assure patient safety.Device not yet received.

Event Description

The sales representative reported on behalf of the customer that the dis150 disposable marked spring tip guidewire was being used on (b)(6) 2023 during a rigid esophageal dilation and the ¿spring tip snapped during procedure and cut patients' esophagus¿.There was a small cut to patient¿s esophagus / discomfort after the procedure.After further assessment it was found that the procedure was not completed, "the patient's esophagus perforated from the wire breaking at the spring tip." the dis150 was utilized as a guide for a rigid dilator - used normally at the time of the event.This was the first use of the dis150.The perforation required x-tack suturing.There was a delay to the procedure, the sales representative stated, ¿i am unsure of the length, but management of the perforation added time to the procedure.¿ the patient initially felt slight discomfort post-procedure.The sales representative stated, ¿i have not heard anything from the hospital so i would assume the patient is fine.The patient stayed longer than normal post-procedure - i am unsure the exact length of time.The patient was able to return home that day.".This report is being raised on the basis of injury due to cut to esophagus.

Manufacturer Narrative

Received one dis150 in opened original packaging.Lot number was verified.Performed a visual inspection, the spring is bent/ broken.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.A two-year review of complaint history revealed there has been a total of 16 reports, regarding 16 devices, for this device family and failure mode.During this same time frame 101,203 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 0.0002.Per the instructions for use, the user is advised the following: 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.The 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.Note: the marking bands are used to determine the location of the distal spring tip from the dentures: 2 bands = 40 cm, 5 bands = 100 cm, 3 bands = 60 cm, 6 bands = 120 cm, 4 bands = 80 cm, 7 bands = 140 cm.A simple formula to remember is to multiply the number of bands by 20 (i.E., 2 x 20 = 40 cm).In many patients, the reference points to the dental arch will be between the second and third bands.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: robin drum ; 11311 concept blvd.; largo, FL 33773 ; 8653881978
• MDR Report Key: 16554445
• MDR Text Key: 311416086
• Report Number: 3007305485-2023-00061
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10653405986553
• UDI-Public: (01)10653405986553(17)241213(10)202212145
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DIS150
• Device Catalogue Number: DIS150
• Device Lot Number: 202212145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 04/06/2023
• Supplement Dates FDA Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic