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

Model Number	596024032
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The jade otw.018" 200cm (percutaneous transluminal angioplasty) pta balloon was used for treatment of 99% stenosed, heavily calcified, in-stent restenosis (isr) lesion in superficial femoral artery (sfa) via radial access 6fr guiding sheath was in use.The non-csi/non-abbott atherectomy catheter had difficulty tracking on the viperwire advance guide wire with flex tip but atherectomy was able to be performed on the isr lesion.There was no allegation of malfunction against the viperwire.The viperwire and non-csi/non-abbott atherectomy catheter were removed.The jade otw balloon was advanced over the non-csi/non- abbott workhorse frontline guide wire into the isr and inflated at sixteen atmospheres (atm).The nominal pressure is fourteen atm and the bursting pressure is eighteen atm.During inflation, the patient bent their leg that was being treated.The balloon burst.The burst balloon had three components.The major part was attached to the catheter and was removed along with the second part.Cine angiographic imaging and fluoroscopy revealed the third component remained in the right brachial artery.Mechanical aspiration was attempted via radial access to snare the fractured component but failed.Mechanical aspiration was then attempted via femoral access which also failed.A technique using a non-csi/non-abbott catheter also failed to retrieve the fractured component.The procedure was aborted, and the patient was sent to hospital for surgical removal of the fractured component.The third component of the fractured part was successfully removed at a different facility.The patient was stable.
Additional Manufacturer Narrative
Manufacturer report number: 3003775186-2024-00178 (b)(4).
Additional Manufacturer Narrative
Updated fields: b4, f6, f8, h11 correction: f10 (impact code-f).F6 represents the aware date of the corrected information.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: 19299306
• Report Number: 3004742232-2024-00186
• Device Sequence Number: 6865212
• Product Code: LIT
• UDI-Device Identifier: 06934955904936
• UDI-Public: (01)06934955904936(11)230607(17)250607(10)5923422305
• Combination Product (Y/N): N
• 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): 06/06/2024
• Report Date (Section F): 05/13/2024

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: 06/07/2025
• Device Model Number: 596024032
• Device Catalogue Number: 7-10085-84
• Device Lot Number: 5923422305
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/06/2024
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/07/2024
• 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: Unknown
• Date Report Sent to FDA: 05/13/2024