MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD JADE 14 OTW PTA BALLOON DILATATION CATHETER; Catheter, angioplasty, peripheral, transluminal

Catalog Number	585015022
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a non-dilatable, heavily calcified, heavily tortuous superficial femoral artery with chronic total occlusion was attempted to be treated with several unspecified balloons, all unsuccessfully.When a jade pta otw 5 x 150 mm balloon was attempted to be used, it ruptured when it reached roughly 22-24 atmospheres.The ruptured component came entirely off the shaft.There was a delay of a few hours while the physician placed stents.Additionally, a cut down of a clot in the common femoral was performed.The hypotube was able to be removed from the common femoral during this time, however, the ruptured components remained in-vivo.The physician attempted to retrieve the components; however, they were difficult to be identified with angiographic imaging and therefore, stents were placed in the area where the balloon ruptured.The physician believed the stents were able to cover the ruptured component.At the end of the procedure, it was indicated that the flow was sufficient and the procedure was completed.The patient was in stable condition.No case image/cd and other information was provided for analysis.

• 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: 21728429
• Report Number: 3003775186-2025-00094
• Device Sequence Number: 11694567
• Product Code: LIT
• UDI-Device Identifier: 06934955901270
• UDI-Public: (01)06934955901270(11)230925(17)250925(10)5848742309
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2025

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: 585015022
• Device Lot Number: 5848742309
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2025
• Initial Report FDA Received Date: 03/29/2025
• 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 Age: 53 YR
• Patient Sex: Male