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

Model Number	582524032
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Mfr report #: 3003775186-2023-02475.Updated fields: b4 & f7.Csi id: (b)(4).
Event or Problem Description
During treatment of an 80%-90% mixed calcified plaque/lesion which was approximately 2.0 mm- 2.5 mm in length, in the distal posterior tibial artery, the jade balloon separated from the catheter on exiting the sheath during the procedure.The balloon was initially inflated at lesion site.There was difficulty to remove the orbital atherectomy device (oad) after balloon deflation.However, the balloon was pulled and eventually removed.After physical inspection and results from angiography showed a part of balloon at the site of inflation and this part of the balloon was left in the leg.
Additional Manufacturer Narrative
Csi id: (b)(4).

• 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: 19829743
• Report Number: 3004742232-2024-00273
• Device Sequence Number: 8159507
• Product Code: LIT
• UDI-Device Identifier: 06934955901621
• UDI-Public: (01)06934955901621(11)230714(17)250714(10)5833202307
• 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): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2024
• Report Date (Section F): 07/25/2024

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: 07/14/2025
• Device Model Number: 582524032
• Device Catalogue Number: 7-10076-24
• Device Lot Number: 5833202307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/21/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 08/06/2024
• 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: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/25/2024