MAUDE Adverse Event Report: MICRO-TECH(NANJING) CO.,LTD. ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE

Catalog Number EUS-22-1-N

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 05/27/2021

Event Type  Injury  

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.We also reviewed the complaint and adverse event history.There are no similar incidents occurred in the last 12months.On (b)(6) 2021, we communicated with our distributor and got the latest information.Current status of patient : stabilised.The purpose of the biopsy is heterogeneous liver.Level of vascularity of the puncture site : normal.The specific location of the lesion to be punctured is left liver.There was only one puncture.The device worked properly during the intervention.There was no abnormalities during the procedure.The device was discarded.No photo or video was provided related to this incident.However, we are trying to collect more information to help us analyze this incident.A follow-up report will be filed following the completion of the incident investigation.

Event Description

On 06/08/2021, we received a complaint from the distributor.It was reported that post puncture hemorrhage of the liver with hematoma greater than 7 cm and anemia.Emergency hospitalisation the day after the examination.Current status of patient : stabilised.

Manufacturer Narrative

On (b)(6) 2021, we communicated with our distributor and got the latest information.Current status of patient : stabilised.The purpose of the biopsy is heterogeneous liver.Level of vascularity of the puncture site : normal.The specific location of the lesion to be punctured is left liver.There was only one puncture.The device worked properly during the intervention.There was no abnormalities during the procedure.The device was discarded.No photo or video was provided related to this incident.After analysis, the causes of puncture hemorrhage may be the following: 1) hemorrhage due to poor puncture caused by damage to the tip of the puncture needle.2) puncture with sheath dislodged during puncture.3) complications.Analysis of the above possible causes of hemorrhage: 1.Damaged puncture needle tip.Raw materials: according to the batch information and investigation of dhr records, all raw materials were inspected and qualified for storage (we tested the stiffness and toughness as well as the dimensions of the raw materials of the needles and carved needles, and the results were qualified), and no abnormalities were found during the process, inspection process and packaging process, and all inspection items were qualified.In summary, the possibility of damage to the raw material tip of the puncture needle is small.Production process: the puncture needle is a cobalt-chromium alloy with good stiffness and toughness, and the tip of the needle is completely shrunken inside the sheath from the end of the production inspection until use, and there is a probe to support and protect the puncture needle, which will not lead to deformation of the tip.In summary, the production process leads to puncture needle tip damage is less likely.Packaging and transportation check: the finished product is packed and shipped in a special packaging suction plastic box, the needle tip is fixed in the outer sheath, and there is a support wire protection, the packaging and transportation method is verified by packaging, the existing packaging and transportation scheme meets the product performance requirements, so the probability of damage to the needle tip of the puncture needle caused by packaging and transportation is extremely low.In summary, we consider that the possibility of damage to the tip of the needle is extremely low.2.Puncture with sheath dislodged during puncture the outer sheath tube is made of peek and has an outer diameter larger than the puncture needle and a cross-sectional area larger than the puncture needle, which if performed together would result in an oversized puncture hole and result in hemorrhage.The outer sheath is fixed to the upper core rod by glue and pressure block.During the sampling process, the outer sheath tube is stationary relative to the handle, and only the puncture needle is active, and the process check will confirm the connection force to ensure that it will not fall off.The customer feedback is that the operation is normal during puncture and the operation is completed normally.Therefore, the outer tube is not dislodged leading to puncture with the outer sheath tube, not resulting in hemorrhage.3.Complications 3.1after checking the relevant literature, hemorrhage is one of the common complications of the use of this product.(1) intraluminal or extraluminal hemorrhage seem to be the most frequent complications of eus-fna,occurring in as many as 4% and 1.3% of cases, respectively.[1] (2) self-limiting mild intraluminal hemorrhage due to eus-fnb has been reported in up to 4% of cases.A prospective study evaluating the risk of extraluminal hemorrhage caused by eus-fna found only three cases among 227 patients (1.3%).[2] 3.2 check the ifu of eus needle.Potential complications: potential complications associated with ultrasound endoscopy include, but are not limited to: perforation, hemorrhage, aspiration, fever, infection, allergic reaction to medication, hypotension, respiratory depression or arrest, cardiac, arrhythmia or arrest and tumor seeding.From the above literature research and ifu, hemorrhage is a common complication of using eus needles.Conclusion: hemorrhage is one of the possible complications of eus operation, we have already indicated it in the eus needle ifu.From the statistical data, the probability of hemorrhage with our eus needle is much lower than the probability of hemorrhage with the eus needle in the literature.The benefit exceeds the risk, and the product risk is acceptable.We will keep monitor on such issues to ensure patient safety.Reference: [1] (b)(6).[2] (b)(6).

• Brand Name: ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
• Type of Device: ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
• Manufacturer (Section D): MICRO-TECH(NANJING) CO.,LTD.; no.10 gaoke third road; nanjing national hi-tech, indu; nanjing, jiangsu 21003 2; CH 210032
• MDR Report Key: 12030597
• MDR Text Key: 267712303
• Report Number: 3004837686-2021-00004
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• PMA/PMN Number: K172309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2021
• Device Catalogue Number: EUS-22-1-N
• Device Lot Number: ME191217171
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 80 YR
• Patient Weight: 70