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

Model Number 606010022

Device Problem Material Rupture (1546)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/23/2023

Event Type  Injury  

Event Description

A jade balloon burst between twenty and twenty-two atmospheres and became stuck on a newly implanted stent in the arteriovenous (av) fistula.The balloon fractured inside the av grand and pieces were unable to be retrieved.An artery compression device was placed on site.The patient was stable.According to the physician, the event was due to patient anatomy.

• Brand Name: JADE PTA BALLOON DILATATION CATHETER
• Type of Device: PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.; no. 1 jinkui road, futian free; shenzhen, 51803 8; CH 518038
• MDR Report Key: 16781157
• MDR Text Key: 313691852
• Report Number: 3004742232-2023-00113
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 606010022
• Device Lot Number: 6011212209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2023
• Distributor Facility Aware Date: 03/23/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Race: White