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

Catalog Number L540-50240

Device Problems Material Separation (1562); Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 06/17/2021

Event Type  Injury  

Event Description

Dr realized that was no jade's tip while removing the jade from the wire.The jade, 5.0mm x 240mm was inflated and deflated in sfa after the whole procedure dr managed to find the broken tip on the guidewire when removing the whole system.Jade will be return to hk for investigation.

• Brand Name: JADE PTA BALLOON DILATATION CATHETER
• Type of Device: PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
• Manufacturer (Section D): ORBUSNEICH MEDICAL CO. LTD; 1 jinkui road,; futian free trade zone; shenzhen 518038,, shenzhen 518038, 51803 8; CH 518038
• MDR Report Key: 12047595
• MDR Text Key: 257747596
• Report Number: 3014148220-2021-02145
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: L540-50240
• Device Lot Number: 5303752104
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/18/2021
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention