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

Catalog Number	596015022
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following laser atherectomy, the jade balloon was used in the superficial femoral artery (sfa) in an 80mm segment.The balloon advanced and inflated with no issues, however, the artery could not open up upon inflation.Several attempts were made and the segment decreased from 80mm to 40mm, however, could not open further.During treatment, the balloon ruptured.When the balloon was at the 6f sheath, the balloon accordioned and upon the catheter removal, the balloon membrane remained in vivo at the external iliac/femoral location.The patient was transferred to a hospital to perform surgery to remove the fragment.The component was successfully removed.The patient was admitted for overnight observation.The patient was stable with no consequences.

• 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.1st jinkui road; futian free trade zone; shenzhen, guangdong 51803 8; CH 518038
• MDR Report Key: 23640814
• Report Number: 3014148220-2025-00458
• Device Sequence Number: 21260658
• Product Code: LIT
• UDI-Device Identifier: 06934955903939
• UDI-Public: (01)06934955903939(11)250311(17)270311(10)5911072503
• Combination Product (Y/N): N
• 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): 11/25/2025

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: 596015022
• Device Lot Number: 5911072503
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/29/2025
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/24/2025
• 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