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

Catalog Number	DG-18-08-21
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Perforation of Esophagus (2399)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported that monday, on (b)(6) gi tech (b)(6) and dr.(b)(6) had an esophageal perforation while using microtech's spring tip guidewire.The account was trailing microtech's guidewire.(b)(6) said while teaching the dr was advancing the savory 1:1 between marking point 3 and 4 on the guidewire.The physician felt no resistance during advancement of savory.There was a dent or kink seen between the 3 and 4 landing mark on our guidewire.A perforation occurred and the patient was admitted and is recovering as expected.The dr placed a 25mm by 155 esophageal stent.During the team debrief the dr & tech concluded the guidewire caused to the perforation.
Additional Manufacturer Narrative
1.Incident description: it was reported that monday, september 30th gi tech (b)(6) and dr (b)(6) had an esophageal perforation while using microtech's spring tip guidewire.The account was trialing microtech's guidewire.(b)(6) said while teaching the dr was advancing the savory 1:1 between marking point 3 and 4 on the guidewire.The physician felt no resistance during advancement of savory.There was a dent or kink seen between the 3 and 4 landing mark on our guidewire.A perforation occurred and the patient was admitted and is recovering as expected.The dr placed a 25mm by 155 esophageal stent.During the team debrief the dr & tech concluded the guidewire caused to the perforation.2.External investigation: 2024/10/03, further information received from the customer.This customer is the first time to use the guidewire products of micro-tech, and there is no abnormality observed before the use of the guidewire, and the patient is a 75-year-old female who has esophageal perforation when the guidewire is used with a dilator (diversatek).The customer provided 2 photos, and there was no abnormal appearance such as guidewire dents or kinks reported by the customer from the photos.3.Internal investigation: the following are investigated and analyzed from the aspects of raw materials, production process, use methods, storage and transportation, and finished product inventory confirmation: 3.1 raw material inspection: inquire about the batch number of complaint, the material, appearance and size of the raw materials are all inspected and put into storage, check the existing raw material inventory of guidewire products, and no abnormalities such as appearance dents, kinks, and fractures are found, so the risk of complaints caused by raw materials is small.3.2 production process investigation: in the production process of guidewire products, we only wipe and inspect the product, and will not do other processing actions.At the same time, the flow chart of guidewire products stipulates a number of inspection processes, including: raw material incoming sampling, 100% full process inspection, finished inspection, qc sampling, and factory sampling after sterilization.Each inspection site stipulates the appearance inspection requirements: "the appearance is neat, and the connection between the soft head and the guidewire rod should be free of burrs and gaps; the surface is smooth without steps, no burrs, needs to be degreased, and cleaned, and there can be no rust."if there are dents or kinks reported by customers, poor production can be detected in time, and the risk of bad outflow is small.3.3 use methods: the instructions for the guidewire product clearly describe.The "warnings", "preparation" and "instructions for use": 3.3.1 warnings are as follows: "1.The product is intended for single use only.2.The product is only intended for adult populations.3.The instrument is intended for use under the direct supervision of a suitably trained physician only.A thorough understanding of the technical principles, clinical applications, and associated risks is expected before usage.4.Confirm that the endoscopy view is clear before use.Do not insert the instrument into the endoscope unless you have a clear endoscopic field of view.Insertion without clear endoscopic field of view could cause patient injury, such as perforation, hemorrhage or mucous membrane damage.Damage to the endoscope and/or the instrument may also occur." 3.3.2 preparation matters:" 1.Reference the product label and choose the appropriate device.2.Contents supplied sterile.3.Inspect the package before use for any damage.Do not use if package is damaged.Open the package carefully after verifying the shelf life.4.Carefully remove the device from its packaging and uncoil it.Do not use excessive force as this may damage the device and affect performance.5.Before use, check the guidewire to ensure that there are no sharp edges.6.Lf this device shows any signs of damage, do not use.Do not attempt to repair a nonfunctional or damaged device.7.Before use, it should be noted that the diameter of the guide wire should be smaller than the diameter of the channel, and the length of the guide wire should be greater than the length of the channel." 3.3.3 the instructions for use specify:" 1.Perform screening endoscopy and identify strictured area 2.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.3.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.4.Marked position of guide wire and dilator should be observed during operation, to prevent damage to human tissues or organs.5.Remove the guide wire and the dilator together after completing the expansion of the strictured area" analysis: the precautions for the use of the product have been warned in the warning items in the manual, and the preparation items have clarified that the product is not damaged before use, and the specific use method is described in the instructions for use.The description is clear and unambiguous, so we confirm that the user will not be inappropriately operated due to the unclear description of the usage method, resulting in this complaint.4.Storage and transportation: for the storage and transportation of single-use marked spring tip guidewire, we have clear requirements: 4.1 store the instrument in the sterile package at room temperature in a clean and dry environment.4.2 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 been perfected in the design and development stage to prove the validity period, confirming that single-use marked spring tip guidewire is safe and effective within the validity period, and the disposable marker spring tip guidewire has also been confirmed for transportation, and 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 were sure that the storage and transportation would not lead to s single-use marked spring tip guidewire appearance, dents, kinks, etc.5.Finished goods inventory confirmation check the inventory of micro-tech's existing finished product warehouse, a total of three batch numbers, m240907101, m240907105, and m240910104, which have been confirmed by technical and quality personnel to jointly inspect and confirm, and no abnormalities such as dents and kinks in the appearance of the guidewire have been found.6.Summary: after internal inventory inspection of raw materials, no abnormalities such as guidewire dents and kinks were found; from the production process, the appearance of the product will be 100% fully inspected in the process, and the risk of leakage is small; from the instructions for use of the product, the instructions clearly stipulate the precautions for the use of the product, the inspection items before use and the detailed use method, and the description is clear and clear, resulting in a small risk of complaints; from the perspective of storage and transportation, the product has clear storage and transportation requirements, resulting in a small risk of dents or kinks in the appearance of the product; check the appearance of the products in the existing finished product warehouse, and no abnormalities such as dents and kinks in the appearance are found.According to the above investigation, the risk of abnormal appearance of the guidewire in the whole production process is small, and we believe that the use of the tip guidewire and the dilator together has a low risk of perforation due to dents or kinks of the guidewire, combined with the low probability of historical complaints, it is recommended to continue to pay attention to market feedback.

• Brand Name: SINGLE-USE MARKED SPRING TIP GUIDEWIRE
• Common Device Name: 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: 20394683
• Report Number: 3004837686-2024-00008
• Device Sequence Number: 18152061
• Product Code: OCY
• UDI-Device Identifier: 06932503525114
• UDI-Public: (01)06932503525114(17)260402(10)M240403102
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

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?: Yes
• Device Expiration Date: 04/02/2026
• Device Catalogue Number: DG-18-08-21
• Device Lot Number: M240403102
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown