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

Model Number	596008022
Medical Device Problem Codes	Entrapment of Device (1212); Material Rupture (1546)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer regulatory report: 3003775186-2024-00328.Csi id: (b)(4).
Event or Problem Description
A 6mm, 80% stenosed, heavily calcified popliteal artery (pa) was the target treatment area.The jade balloon was advanced with the aid of a command es guide wire.The jade balloon was inflated multiple times to 28 atmosphere pressure (atm), past the burst pressure, resulting in a balloon rupture.When attempting to remove the jade balloon, it could not be removed.A snare was used but was unsuccessful.The patient was transported to the hospital for surgery and had the jade balloon removed.The patient was stable.Additional information received on 9/06/2024, the patient is still hospitalized.The physician stated, the jade balloon wasn't intentionally inflated to burst but was inflated past burst pressure due to a very resistant lesion.When the jade balloon ruptured, no detachment was observed.The collapsed jade balloon could not be successfully removed without surgery intervention.

• Brand Name: JADE PTA BALLOON DILATATION CATHETER
• Common Device Name: PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
• Manufacturer (Section D): ORBUSHNEICH MEDICAL CO., LTD.; no. 1 jinkui road; futian free trade zone; shenzhen 51803 8; CH 518038
• MDR Report Key: 20301639
• Report Number: 3004742232-2024-00333
• Device Sequence Number: 15350482
• Product Code: LIT
• UDI-Device Identifier: 06934955903908
• UDI-Public: (01)06934955903908(11)231004(17)251004(10)5947542309
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/25/2024
• Report Date (Section F): 10/04/2024

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: 10/04/2025
• Device Model Number: 596008022
• Device Catalogue Number: 7-10084-79
• Device Lot Number: 5947542309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/04/2024
• Device Age: 11 MO
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 09/05/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2024
• 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; Hospitalization
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Date Report Sent to FDA: 10/04/2024