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

Model Number	586024022
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During procedure using a jade balloon inside a stent in superficial femoral artery (sfa), the balloon ruptured during retrieval when the balloon got stuck on the strut of the stent and got deflated.It ripped the balloon in half.The distal tip of the balloon was retrieved using a snare.No fragments were left in-vivo.The balloon was not inflated at all.There was clinically significant delay to the procedure.The patient was stable, and a replacement balloon was used to complete the procedure without any issues.
Additional Manufacturer Narrative
Manufacturer report number: 3003775186-2024-00314.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: 20156193
• Report Number: 3004742232-2024-00329
• Device Sequence Number: 4248217
• Product Code: LIT
• UDI-Device Identifier: 06934955901386
• UDI-Public: (01)06934955901386(11)231120(17)251120(10)5862452311
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/06/2024
• Report Date (Section F): 09/06/2024

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: 11/20/2025
• Device Model Number: 586024022
• Device Catalogue Number: 7-10075-69
• Device Lot Number: 5862452311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/15/2024
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2024
• 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: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 09/06/2024