MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. JADE PTA BALLOON DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	585024022
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during procedure to treat 80% stenosed heavily calcified left superficial femoral artery (sfa), the jade balloon was inflated to 16-18 atmospheres (atm) and burst.Upon removal, the balloon membrane separated from the catheter.The balloon membrane was all successfully retrieved using a snare with nothing left in-vivo.No further complications occurred and the patient was in stable condition.The physician believed the balloon burst due to the calcified artery.The date of event will be estimated as 04/23/2025.
Additional Manufacturer Narrative
The date of event will be estimated as 04/23/2025.

• Brand Name: JADE 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; shang hai shi, shanghai 51803 8; CH 518038
• MDR Report Key: 22035440
• Report Number: 3004742232-2025-00141
• Device Sequence Number: 8641671
• Product Code: LIT
• UDI-Device Identifier: 06934955901294
• UDI-Public: (01)06934955901294(17)260924(10)5848702409
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/16/2025
• Report Date (Section F): 05/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/24/2026
• Device Model Number: 585024022
• Device Catalogue Number: 585024022
• Device Lot Number: 5848702409
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/24/2025
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 75 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 05/16/2025