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

Model Number	586024022
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A jade balloon ruptured in-vivo after treatment of a 80% stenosed, severely calcified, 6mm mid superficial femoral artery.A piece of the balloon was left in the patient.A snare was used to retrieve the fractured component.The patient was in stable condition.
Additional Manufacturer Narrative
Csi id: (b)(4).
Additional Manufacturer Narrative
Manufacturer regulatory report number: 3003775186-2024-00282.Updated fields: b4, f6, f7, f8, f11.Csi id: (b)(4).
Event or Problem Description
A jade balloon ruptured in-vivo after treatment of a 80% stenosed, severely calcified, 6mm mid superficial femoral artery.A piece of the balloon was left in the patient.A snare was used to retrieve the fractured component.The patient was in stable condition.

• Brand Name: JADE PTA
• Common Device Name: PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.; no. 1 jinkui road, futian free; shenzhen, 51803 8; CH 518038
• MDR Report Key: 20077023
• Report Number: 3004742232-2024-00324
• Device Sequence Number: 6574100
• Product Code: LIT
• UDI-Device Identifier: 06934955901386
• UDI-Public: (01)06934955901386(11)231104(17)251104(10)5858072310
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2024
• Report Date (Section F): 08/30/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/04/2025
• Device Model Number: 586024022
• Device Catalogue Number: 7-10075-69
• Device Lot Number: 5858072310
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/30/2024
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 08/30/2024
• 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: Male
• Date Report Sent to FDA: 08/30/2024