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 2026/02/13: 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
• MDR Report Key: 24573476
• Report Number: 3014148220-2026-00082
• Device Sequence Number: 18449959
• 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
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• 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
• Distributor Facility Aware Date: 02/12/2026
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown