MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD JADE 18 OTW PTA BALLOON DILATATION CATHETER; Catheter, angioplasty, peripheral, transluminal

Catalog Number	597004022
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during procedure, a jade balloon ruptured and got trapped in-vivo resulting in surgical cutdown for removal of the balloon.Additional information was received on 2026/2/13: 1.Did the balloon become fully detached or was it damaged intact? part of the balloon became detached as well as the balloon marker.The other half of the balloon was removed from the body 2.Was there any balloon fragments left in-vivo or was it completely removed? it was completely removed with surgery.3.Anatomical information? (vessel / location / tortuosity / calcification / stenosis % / etc.) proximal sfa, heavy calcification, 90-95% stenosis.4.Was there a delay in the procedure that resulted in patient harm? if yes, what was the harm? no 5.Will the facility release any images or films of the incident for review by the engineers? no 6.What is the status of the patient? stable upon completion of the procedure.

• Brand Name: JADE 18 OTW PTA BALLOON DILATATION CATHETER
• Common Device Name: Catheter, angioplasty, peripheral, transluminal
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD; no.1 jinkui road; futian free trade zone; shenzhen, guangdong 51803 8; CH 518038
• Manufacturer (Section G): YLI@ORBUSNEICH.COM; no.1 jinkui road; futian free trade zone; shenzhen, guangdong 51803 8; CH 518038
• Manufacturer Contact: yuki li ; no.1 jinkui road; futian free trade zone; shenzhen, guangdong 51803-8 ; CH 518038
• MDR Report Key: 24565781
• Report Number: 3003775186-2026-00082
• Device Sequence Number: 8569208
• Product Code: LIT
• UDI-Device Identifier: 06934955903991
• UDI-Public: (01)06934955903991(11)250214(17)270214(10)5902122501
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K202231
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 597004022
• Device Lot Number: 5902122501
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown