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

Catalog Number	596008022
Medical Device Problem Codes	Entrapment of Device (1212); Material Rupture (1546)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A 6mm, 80% stenosed, heavily calcified popliteal artery (pa) was the target treatment area.The jade balloon was advanced with the aid of a command es guide wire.The jade balloon was inflated multiple times to 28 atmosphere pressure (atm), when attempting to remove the jade balloon, it could not be removed.A snare was used but was unsuccessful.The patient was transported to the hospital for surgery and had the jade balloon removed.The patient was stable.Additional information received on (b)(6) 2024, the patient is still hospitalized.The physician stated, the jade balloon wasn't intentionally inflated to burst but was inflated past burst pressure due to a very resistant lesion.When the jade balloon ruptured, no detachment was observed.The collapsed jade balloon could not be successfully removed without surgery intervention.Background: patient information: 44 years, male, 110 kg.Additional information was received on 2024/9/14 as below: 1.The vessel was 6mm, 80% stenosed, heavily calcified popliteal artery (pa) 2.To clarify, was the balloon intentionally burst? not intentionally , very resistant lesion 3.How many times was the balloon inflated? if multiple times, at what pressure? multiple times inflated up to 28 atms 4.Please verify, when the balloon ruptured, did it detach from the catheter? the balloon collapsed and was unable to be removed.

• 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
• 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: 20243840
• Report Number: 3003775186-2024-00328
• Device Sequence Number: 12587981
• Product Code: LIT
• UDI-Device Identifier: 06934955903908
• UDI-Public: (01)06934955903908(11)231004(17)251004(10)5947542309
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K202231
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 596008022
• Device Lot Number: 5947542309
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 09/18/2024
• 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: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 110 KG