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

Model Number	596015022
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during procedure, a jade balloon was placed in patient's superficial femoral artery (sfa) and was inflated to 12 atmospheres.The balloon ruptured.During removal, it was noticed that the balloon had broken in-vivo and became completely detached.An attempt was made to advance another wire through the existing 6f non-abbott contralateral sheath, but was unsuccessful.The physician had to puncture the sfa antegrade directly below the broken balloon.A stent was placed with difficulty to adhere the balloon against the wall.There was delay in the treatment as it added 75 to 90 minutes to the procedure with two additional punctures that were required.The patient was discharged after bedrest.
Additional Manufacturer Narrative
Updated fields: d9, f7, f11, f13, h2, h3, h10 h10: manufacturer report number.
Event or Problem Description
It was reported that during procedure, a jade balloon was placed in patient's superficial femoral artery (sfa) and was inflated to 12 atmospheres.The balloon ruptured.During removal, it was noticed that the balloon had broken in-vivo and became completely detached.An attempt was made to advance another wire through the existing 6f non-abbott contralateral sheath, but was unsuccessful.The physician had to puncture the sfa antegrade directly below the broken balloon.A stent was placed with difficulty to adhere the balloon against the wall.There was delay in the treatment as it added 75 to 90 minutes to the procedure with two additional punctures that were required.The patient was discharged after bedrest.

• 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: 22473161
• Report Number: 3004742232-2025-00200
• Device Sequence Number: 19857803
• Product Code: LIT
• UDI-Device Identifier: 06934955903939
• UDI-Public: (01)06934955903939
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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,Followup
• Report Date (Section B): 09/03/2025
• Report Date (Section F): 09/03/2025

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: 07/28/2025
• Device Model Number: 596015022
• Device Catalogue Number: 7-10084-82
• Device Lot Number: 5930132307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/13/2025
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 92 KG
• Patient Race: White
• Date Report Sent to FDA: 09/03/2025