MAUDE Adverse Event Report: MICRO-TECH(NANJING) CO.,LTD. SINGLE-USE MARKED SPRING TIP GUIDEWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number DG-18-08-21

Device Problems Break (1069); Fracture (1260)

Patient Problem Perforation of Esophagus (2399)

Event Date 05/25/2022

Event Type  malfunction  

Event Description

It was reported to micro-tech(nanjing) co.,ltd.That dr.Battaglino was using a savory with guidewire to dilate and stated that he felt resistance with advancing the savory, so removed the savory with the wire and noticed that the spring end of the wire was no longer attached to the rest of the wire that he removed, so then had to go back in to retrieve the broken end.Once reentering, they found that the broken end of the tip that was retained had perforated through the esophagus and possibly into other tissue.That piece was then removed and the crna obtained an advanced airway as he then had a bleed and did have a change in o2 saturation and blood pressure.The patient was transported via ems to wake med, where he underwent surgical repair of the perforation.Here are the photos from the wire that was used.It seems to have broken at one of the distance marker sites.Rec from customer on 5/27/2022 - thank you for looking into this.As of now, per dr.Battaglino, the patient is awake and has been extubated, and is doing much better at the moment.He did have surgical repair of an esophageal perforation and also suffered a pneumothorax, requiring chest tube placement as the wire had travelled through esophageal and lung tissue.

Manufacturer Narrative

The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The products released for distribution were found to have met all specifications prior to shipment and found no abnormalities that would contribute to this issue.However, the incident investigation is ongoing.A follow-up report will be filed following the completion of the incident investigation.

Manufacturer Narrative

The procedure was at the asc.Arizona advanced endoscopy, patient 65 years old with polyps in the sigmoid colon, a 20 mm pedunculated polyp.According to the complaint pictures provided by the customer, it can be seen that the tip guidewire was broken during the operation, combined with the process failure mode of the product.We find out all the processes that may cause this kind of failure and analyze them one by one.1.Structural design this single-use marked spring tip guidewire is composed of a spring soft and a guidewire rod.Analysis: the working principle of a single-use marked spring tip guidewire is as follows: "find the location of the human body cavity where demand expands under the endoscopic monitoring; insert the spring tip of the guide wire into the appropriate endoscopic channel and reach the position that needs to be expanded, then fix it.Slowly insert the probe along the other end of the guide wire to the position that needs to be expanded.During the operation, it is necessary to observe the mark position of the guide wire and the probe to prevent the insertion of too deep and damage to human tissues or organs; after the expansion purpose is completed, the guide wire is inserted.The tip guidewire and the savory are removed together." from jan 2019 to may 2022, the cumulative shipments of single-use marked spring tip guidewire of this design are about (b)(4) for the first time, the customer complaint of guide wire breakage was received, indicating that the structural design is stable and reliable.Therefore, it is determined that the structural design of the single-use marked spring tip guidewire can meet the clinical requirements.This customer complaint feedback has nothing to do with the structural design of the single-use marked spring tip guidewire.2.Raw material check that the material, appearance and size of this batch of raw materials are all qualified.3.Manufacturing process during the production process, we only wipe and inspect the product, and do not do other processing actions.Process inspection process: the appearance is clean, the connection between the spring soft and the guidewire rod should be free of burrs and gaps, the surface is smooth without steps and burrs, and needs to be degreasing and cleaned.Analysis: we checked the relevant processes, in which the process inspection will conduct 100% inspection on the appearance of the product.If there are cracks or other poor appearance of the production line, it can be found in time.4.Instructions for use perform screening endoscopy and identify strictured area.Insert the spring tip of the guide wire into the appropriate endoscopic channel and advance until it is endoscopically visualized beyond the tip of the scope.When the guide wire is in position beyond the strictured area, withdraw the endoscope and slowly insert the dilator along the other end of the guide wire to the strictured area.Marked position of guide wire and dilator should be observed during operation, to prevent damage to human tissues or organs.Remove the guide wire and the dilator together after completing the expansion of the strictured area.Analysis: this single-use marked spring tip guidewire is described as a guide wire breakage during use.The ifu clarifies the method of use: ".When the guide wire is in position beyond the strictured area, withdraw the endoscope and slowly insert the dilator along the other end of the guide wire to the strictured area." the description is clear and clear and will not cause ambiguity, so we confirm that it is not.This customer complaint will be caused by the user's improper operation due to the unclear description of the use method.5.Storage transport store the instrument in the sterile package at room temperature in a clean and dry environment.Do not store the instrument in direct sunlight.Ensure that the package is not crushed by surrounding objects during storage.Analysis: the single-use marked spring tip guidewire has undergone a complete validity period during the design and development stage, confirming that the single-use marked spring tip guidewire is safe and effective within the validity period, while the single-use marked spring tip guidewire is safe and effective.The guide wire has also been confirmed for transportation to determine that the packaging method can meet the protection needs of the product, and more detailed storage and transportation conditions are also detailed in the manual.Therefore, we determined that the way of storage and transportation will not cause the single-use marked spring tip guidewire to break.6.Inventory confirmation after receiving the complaint, we randomly selected a batch of raw materials & 7 batches of finished products, and tested the tensile force and brittle breaking force of the selected (b)(4) pcs products.The test results are as follows: tensile breaking force : the wire was not broken after the test, the tensile breaking force showed (b)(4); brittle breaking force : the brittle fracture force ranged from 176n to 254n, and 3 samples were fractured, and the fracture forces were 176n/198n/213n respectively; we checked the product performance specification for single-use marked spring tip guidewire, there is no requirement about mechanical character.The tip guide wire was used with dilator, there is no chance to break the wire under routine operations.At the same time, from jan 2019 to may 2022, the cumulative shipments of products of this design are about (b)(4), and the first time a customer complaint about a broken product is received.The probability of occurrence is 1.25*10-5, and the probability of occurrence is very low.Conclusion: after the internal structure design, raw materials, production process, instructions for use, transportation and testing of the retained samples, no possible cause of the abnormality has been found.We believe that the tip guide wire and savory are used together, and the risk of guide wire breakage is low.This is the first time that this has occurred, and we will continue to pay attention to market feedback.

• Brand Name: SINGLE-USE MARKED SPRING TIP GUIDEWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): MICRO-TECH(NANJING) CO.,LTD.; no.10 gaoke third road; nanjing national hi-tech, indu; nanjing, jiangsu 21003 2; CH 210032
• Manufacturer (Section G): MICRO-TECH(NANJING) CO.,LTD.; no.10 gaoke third road; nanjing national hi-tech, indu; nanjing, jiangsu 21003 2; CH 210032
• Manufacturer Contact: becky li ; no.10 gaoke third road; nanjing national hi-tech, indu; nanjing, jiangsu 21003-2 ; CH 210032
• MDR Report Key: 14741739
• MDR Text Key: 302190226
• Report Number: 3004837686-2022-00001
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 06932503525114
• UDI-Public: (01)06932503525114(17)230918(10)M201919102
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2023
• Device Model Number: DG-18-08-21
• Device Catalogue Number: DG-18-08-21
• Device Lot Number: M210919102
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other