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

Model Number DIS150

Device Problem Material Twisted/Bent (2981)

Patient Problem Perforation (2001)

Event Date 01/20/2022

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.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 device, (b)(4), disposable marked spring tip guidewire was being used during an egd dilation on 20jan22 and ¿(b)(4) bent and perforated the patient¿.The procedure was not completed as the ¿patient sent to surgery after perforation." further assessment has been sent; however, no response has been received to date.This report is being raised on the basis of injury as the device perforated the patient.

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.

Event Description

The sales representative reported on behalf of the customer that the device, dis150, disposable marked spring tip guidewire was being used during an egd dilation on (b)(6) 2022 and ¿dis150 bent and perforated the patient¿.The procedure was not completed as the ¿patient sent to surgery after perforation." further assessment has been sent; however, no response has been received to date.This report is being raised on the basis of injury as the device perforated the patient.

Manufacturer Narrative

Reported event of device broken/bent is confirmed.Received one dis150 in unoriginal packaging.Lot number was not verified.Performed a visual inspection, the spring tip is broken, and the wire is bent, creating sharp edges.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 3 reports, regarding 3 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

Update: further assessment information was received on 16feb22.Per the reporter, "the examined esophagus was normal.A guidewire was placed and the scope was withdrawn.Dilation was performed with a savary dilator with no resistance at 54 fr.The dilation site was examined following endoscope reinsertion and showed moderate mucosal disruption and large esophageal tear related to a wire damage.A new wire was used for this procedure.Savary dilator passed easily but upon removal of dilator and wire wire was noted to be caught and difficult to extract from the mouth.Egd scope was passed into esophagus and showed that the wire was attached into esophagus at site of the significant twist of the guidewire.After removal of wire, it was noted to be kinked and twisted.Distal esophagus showed significant tearing." the device was inspected prior to use and no anomalies were noted.Resistance (on the guidewire) was encountered upon removal and that is when the kink was discovered.The patient has been discharged and is in stable condition.There was pro-longed hospitalization of 7 days.The sales representative reported on behalf of the customer that the device, dis150, disposable marked spring tip guidewire was being used during an egd dilation on 20jan22 and ¿dis150 bent and perforated the patient¿.The procedure was not completed as the ¿patient sent to surgery after perforation." further assessment has been sent; however, no response has been received to date.This report is being raised on the basis of injury as the device perforated the patients esophagus requiring additional surgery.

• 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: 13525304
• MDR Text Key: 285568926
• Report Number: 3007305485-2022-00014
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10653405986553
• UDI-Public: (01)10653405986553(17)231118(10)202111184
• 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: 03/31/2022

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 Expiration Date: 11/18/2023
• Device Model Number: DIS150
• Device Catalogue Number: DIS150
• Device Lot Number: 202111184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2022
• Initial Date FDA Received: 02/14/2022
• Supplement Dates Manufacturer Received: 03/08/2022
• Supplement Dates FDA Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic