MAUDE Adverse Event Report: OrbusNeich Medical (Shenzhen) Co., Ltd JADE 14 OTW PTA Balloon Dilatation Catheter; Catheter, Angioplasty, Peripheral, Transluminal

Catalog Number	586008022
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat lesion in an unspecified right lower extremity artery.During the procedure via common femoral artery access the tip of the 6.0mm x 80mm jade 14 pta otw balloon fractured.Surgical cut-down was performed to remove the balloon tip.No additional information was provided.Additional information was received on (b)(6) 2026: "it was reported that the procedure was to treat heavily calcified, mild tortuous, 90% stenosed lesion in right distal superficial femoral artery (sfa) via common femoral artery access.During the procedure the tip of the 6.0mm x 80mm jade 14 pta otw balloon fractured upon removal of the balloon from the sheath and came off inside the distal sfa stent.Surgical cut-down was performed to remove the balloon tip but was not completely successful.The patient was stable after the procedure and discharged as planned.No additional information was provided.Q1.Anatomical information? (vessel / location / tortuosity / calcification / stenosis % / etc.) please provide reason if unavailable (hospital policy, etc.) a1.Right sfa, distal right sfa heavily calcified, mild tortuosity and 90% stenosis q2.Is there any indication as to how the fracture occurred? a2.Upon removal of the balloon from the sheath the tip of the balloon came off inside the distal sfa stent.Q3.Was the surgery to remove the component completely successful? a3.No.Q4.What was the patient's status after the surgery (stable, discharged as planned, etc.) a4.Stable, patient discharged as planned.Q5.Reason the jade balloon is not returning? (discarded, held by account, etc.) a5.Held by account.

• Brand Name: JADE 14 OTW PTA Balloon Dilatation Catheter
• Common Device Name: Catheter, Angioplasty, Peripheral, Transluminal
• Manufacturer (Section D): OrbusNeich Medical (Shenzhen) Co., Ltd; no.1st jinkui road; futian free trade zone; shenzhen, guangdong 51803 8; CH 518038
• Manufacturer (Section G): OrbusNeich Medical (Shenzhen) Co., Ltd; no.1st jinkui road; futian free trade zone; shenzhen, guangdong 51803 8; CH 518038
• Manufacturer Contact: yuki li ; no.1st jinkui road; futian free trade zone; shenzhen, guangdong 51803-8 ; CH 518038
• MDR Report Key: 25757580
• Report Number: 3003775186-2026-00388
• Device Sequence Number: 9740704
• Product Code: LIT
• UDI-Device Identifier: 06934955901331
• UDI-Public: (01)06934955901331(11)250813(17)270813(10)5841042508
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 586008022
• Device Lot Number: 5841042508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 07/08/2026
• Supplement Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown