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

Catalog Number DIS150

Device Problem Material Twisted/Bent (2981)

Patient Problems Laceration(s) (1946); Laceration(s) of Esophagus (2398)

Event Date 03/06/2024

Event Type  Injury  

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.

Event Description

A sales representative reported on behalf of a customer that the dis150, disposable marked spring tip guidewire device was being used during an esophageal dilation on (b)(6) 2024, and the ¿wire kinked in 2 places after placed in patient.Savary dilator became stuck in patient.¿.Follow-up assessment found that the "savary dilator" was removed from the patient intact."an overtube was placed for the patient's safety, and somehow dr.Was able to dislodge the device with slight, careful movements.The patient had deep mucosal tears/punctures from the wire and/or savary in the stomach and esophagus, which needed 6 clips for closure.The outpatient was closely monitored in our recovery area, but to my knowledge did not require further medical attention.She had no c/o pain once she woke up.She was discharged home.Dr.Recommended a barium swallow and a repeat egd for follow up." the procedure was completed with a delay of 10 minutes and without the use of an alternate same device.This report is being raised on the basis of injury due to the report of deep mucosal tears/punctures.

Event Description

A sales representative reported on behalf of a customer that the dis150, disposable marked spring tip guidewire device was being used during an esophageal dilation on (b)(6) 24, and the ¿wire kinked in 2 places after placed in patient.Savary dilator became stuck in patient.¿.Follow-up assessment found that the "savary dilator" was removed from the patient intact."an overtube was placed for the patient's safety, and somehow dr.Was able to dislodge the device with slight, careful movements.The patient had deep mucosal tears/punctures from the wire and/or savary in the stomach and esophagus, which needed 6 clips for closure.The outpatient was closely monitored in our recovery area, but to my knowledge did not require further medical attention.She had no c/o pain once she woke up.She was discharged home.Dr.Recommended a barium swallow and a repeat egd for follow up." the procedure was completed with a delay of 10 minutes and without the use of an alternate same device.This report is being raised on the basis of injury due to the report of deep mucosal tears/punctures.

Manufacturer Narrative

Received one dis150 in unoriginal packaging.Lot number was not verified.Performed a visual inspection, the wire has "kinks" in it.A root cause cannot be determined, however, based upon the instructions for use; a possible cause of this event could be that resistance was met, and the guidewire was advanced without determining the cause for resistance.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 such occurrence for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised: 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.

• 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 18924400
• MDR Text Key: 337910099
• Report Number: 3007305485-2024-00040
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10653405986553
• UDI-Public: (01)10653405986553(17)260123(10)202401244
• 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: 04/29/2024

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 Catalogue Number: DIS150
• Device Lot Number: 202401244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2024
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Ethnicity: Non Hispanic