MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD JADE 18 OTW PTA BALLOON DILATATION CATHETER; Catheter, angioplasty, peripheral, transluminal

Catalog Number	596024022
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during procedure; the jade balloon was inflated in mid superficial femoral artery (sfa) to 8 atm and it ruptured.The physician attempted to pull the balloon out of the sfa over the wire and it could not move, it just accordion.The pedal access was obtained in an attempt to capture balloon with a snare.Some of the balloon was snared out and a stent was placed to adhere the leftover balloon to the artery wall.

• Brand Name: JADE 18 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
• MDR Report Key: 22948897
• Report Number: 3014148220-2025-00340
• Device Sequence Number: 8530109
• Product Code: LIT
• UDI-Device Identifier: 06934955903953
• UDI-Public: (01)06934955903953(11)250221(17)270221(10)5904462502
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/03/2025

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: 596024022
• Device Lot Number: 5904462502
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/19/2025
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2025
• 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 Sex: Unknown