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

Model Number	585015022
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: manufacturer report number.
Event or Problem Description
It was reported that a non-dilatable, heavily calcified, heavily tortuous superficial femoral artery with chronic total occlusion was attempted to be treated with several unspecified balloons, all unsuccessfully.When a jade pta otw 5 x 150 mm balloon was attempted to be used, it ruptured when it reached roughly 22-24 atmospheres.The ruptured component came entirely off the shaft.There was a delay of a few hours while the physician placed stents.Additionally, a cut down of a clot in the common femoral was performed.The hypotube was able to be removed from the common femoral during this time, however, the ruptured components remained in-vivo.The physician attempted to retrieve the components; however, they were difficult to be identified with angiographic imaging and therefore, stents were placed in the area where the balloon ruptured.The physician believed the stents were able to cover the ruptured component.At the end of the procedure, it was indicated that the flow was sufficient and the procedure was completed.The patient was in stable condition.

• 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: 21775326
• Report Number: 3004742232-2025-00073
• Device Sequence Number: 9821936
• Product Code: LIT
• UDI-Device Identifier: 06934955901270
• UDI-Public: (01)06934955901270(17)250925(10)5848742309
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/04/2025
• Report Date (Section F): 04/04/2025

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: 09/25/2025
• Device Model Number: 585015022
• Device Catalogue Number: 585015022
• Device Lot Number: 5848742309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/12/2025
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2025
• 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: 53 YR
• Patient Sex: Male
• Patient Race: Black Or African American
• Date Report Sent to FDA: 04/04/2025