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

Model Number	581524022
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer report number: 3003775186-2024-00252.Csi id: (b)(4).
Event or Problem Description
During a peripheral procedure to treat 99% diffused stenosed calcified lesion about 2mm-3mm in diameter in right anterior tibial (at) artery via left common femoral approach with a 6 fr 90 cm non-csi abbott sheath, a 1.5mm x 240 mm jade balloon was advanced over a guidewire.The balloon ruptured upon first inflation.Upon removal of the ruptured balloon, it was noticed that the actual balloon had separated off of the delivery catheter and was left in the patient's right at.The physician attempted to retrieve the balloon using a non-csi/abbott snare but was unsuccessful.A second attempt was made via pedal at access approach to retrieve the balloon using a non-csi/abbott snare, which was also unsuccessful.Another 1.5mm x 240mm jade balloon was advanced next to the sheared off balloon in the vessel, in an attempt to inflate and drag the balloon back out of the at, however this was also unsuccessful.After several failed attempts to retrieve the sheared off balloon, the physician decided to leave the balloon in the at.The at was originally occluded at the beginning of the procedure, and hence leaving the balloon in the at did not cause any additional damage and did not block flow, since patient did not have flow to start.The balloon was left in the right at.The physician then treated lesions in posterior tibial (pt) artery after which the patient had pulsatile flow to foot.The popliteal artery and lower superior femoral artery (sfa) were then treated with non- csi/abbott stents.The patient's inflow and outflow were confirmed after a final angiogram.All the devices were then removed closed with a 6f non-csi/abbott closure device in the left common femoral artery.The procedure was delayed, and the patient was in stable condition.

• Brand Name: JADE PTA BALLOON DILATATION CATHETER
• Common Device Name: PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.; no, 1st jinkui road; futian free trade zone; shenzhen, guangdong 51803 8; CH 518038
• MDR Report Key: 19820260
• Report Number: 3004742232-2024-00271
• Device Sequence Number: 8781039
• Product Code: LIT
• UDI-Device Identifier: 06934955900754
• UDI-Public: (01)06934955900754(11)230510(17)250510(10)5821402304
• 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
• Report Date (Section B): 07/24/2024
• Report Date (Section F): 07/24/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/10/2025
• Device Model Number: 581524022
• Device Catalogue Number: 7-10075-06
• Device Lot Number: 5821402304
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/27/2024
• Event Location: Hospital
• Date Report to Manufacturer: 07/11/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Race: White
• Date Report Sent to FDA: 07/24/2024