MAUDE Adverse Event Report: LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD VASC BAND; HEMOSTAT

Model Number 3524

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

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

Event Date 07/18/2023

Event Type  Injury  

Event Description

It was reported that: lhc pci was performed access via the right radial artery on an 80 y/o female with fragile skin integrity.A 6f sheath was used in the procedure.Pci procedure did not have any known issues/complications.It was reported that there was a skin tear beside the access area previous to the pci procedure.Post pci procedure, sheath pulled by md.Vascband placed.The patient was transferred from table to stretcher.It was then reported that there was a large hematoma present proximal to the vascband.A second vascband was placed above the first vascband.Hematoma continued to grow.Both bands were removed, and manual pressure was applied.It was reported that the patient's skin tore, and caused moderate bleeding.No blood transfusion was required.Vascular surgery was consulted and did a pressure dressing.Wound consult was scheduled for the patient.Associated to mdr 3008002401-2023-00006.

Manufacturer Narrative

Email inquiry question: 1) can you confirm the batch information? 2) can you provide a detailed usage process, including the initial inflation amount and how long will it take to deflate? what is the amount of air released? 3) the second compressor is placed above the first compressor.May i ask where the skin tear, hematoma, first compressor, and second compressor are located? can you provide a simple location diagram? 4) in the follow-up complaint, it was stated that "the patient's skin was torn, causing moderate bleeding and no need for blood transfusion".Is this skin tear located at the same location as the skin tear entering the area before pci surgery? 5) may i ask what is the result of the vascular surgeon's consultation on the wound? what harm did this wound cause to the patient? 6) can the product be returned for cause analysis? and got reply: 1) unable to provide lot number, the product packaging has not been saved.No response to other questions.Due to the failure to provide batch number information, the production process was investigated, and the product production inspection process was strictly carried out in accordance with the work instructions.The quality of the product production process is stable and reliable.The feedback in the customer complaint is about the patient's hematoma problem after pci.In response to this situation, it is mentioned in the literature "nursing care of using arterial compressors to stop bleeding after pci through the radial artery" 4.3 that if a hematoma appears above the puncture, an additional compression device should be added above the former one to compress and extend the compression time of the compression device appropriately.If a hematoma appears in the patient's forearm, a bandage should be used to compress and bandage it, which prevents severe bleeding.After surgery, apply local ice packs and closely observe the patient's condition.Due to the failure to provide other information related to the complaint event and the failure to return the relevant products, it is not possible to analyze the cause of this adverse event.

• Brand Name: VASC BAND
• Type of Device: HEMOSTAT
• Manufacturer (Section D): LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD; no.37 chaoqian rd.; changping district; beijing, 10220 0; CH 102200
• Manufacturer (Section G): LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD; no.37 chaoqian rd.; changping district; beijing, 10220 0; CH 102200
• Manufacturer Contact: bo jiang ; no.37 chaoqian rd.; changping district; beijing, 10220-0 ; CH 102200
• MDR Report Key: 18145975
• MDR Text Key: 328225129
• Report Number: 3008002401-2023-00007
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 3524
• Date Manufacturer Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female