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

Model Number	586010022
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Na.
Event or Problem Description
It was reported that the jade balloon was used with a non-abbott sheath via pedal access to treat a lesion in left superficial femoral artery (sfa).The balloon was inflated to 18 atmospheres (atm) for 2 minutes and then deflated.An indeflator remained hooked to balloon at negative pressure while the balloon was removed from the wire.There was resistance and the balloon sheared off at middle point of balloon, leaving half of the balloon about 50 millimeters (mm) in-vivo as it was taken out of the body.New balloons across fragmented balloon were placed to snare the fragment and a snare was used to attempt for removal of the fragment.A stent was placed to adhere balloon against the artery wall.The patient's status was unknown.
Additional Manufacturer Narrative
H10: manufacturer report number.Updated fields: b5, d9, f7, f11, f13, h2, h3, h10.
Event or Problem Description
It was reported that the jade balloon was used with a non-abbott sheath via pedal access to treat a lesion in left superficial femoral artery (sfa).The balloon was inflated to 18 atm for 2 minutes and then deflated.Indeflator remained hooked to balloon at negative pressure while balloon was walked of wire.There was resistance and the balloon sheared off at middle point of balloon, leaving half of the balloon about 50mm in-vivo as it was taken out of the body.New balloons across fragmented balloon was placed to snare the fragment and a snare was used to attempt for removal of the fragment.A stent was placed to adhere balloon against the artery wall.Additional information was received and the patient was discharged.

• 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: 22742963
• Report Number: 3004742232-2025-00230
• Device Sequence Number: 18223356
• Product Code: LIT
• UDI-Device Identifier: 06934955901348
• UDI-Public: (01)06934955901348
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/04/2025
• Report Date (Section F): 09/04/2025

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: 06/20/2026
• Device Model Number: 586010022
• Device Catalogue Number: 7-10075-65
• Device Lot Number: 5827242406
• 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: 07/15/2025
• Event Location: Hospital
• Date Report to Manufacturer: 09/04/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/04/2025
• 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: 58 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 09/04/2025