MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO. LTD JADE; JADE OTW

Lot Number 5900522101

Device Problems Stretched (1601); Patient-Device Incompatibility (2682)

Patient Problem Vascular Dissection (3160)

Event Date 10/20/2021

Event Type  Injury  

Event Description

A jade balloon was used in the left superficial femoral artery (sfa) via contralateral access with a 6fr sheath.Laser atherectomy was used prior for a neointimal hyperplasia in stent restenosis.The 6.0mm jade balloon was applied post laser treatment.The balloon marker was placed at the distal end of the 6.0mm stent.When the balloon was inflated, it elongated outside of the stent.The physician opinion is that this led to a dissection in the popliteal artery.A 4.0mm jade balloon long inflation to try and resolve the dissection.(there was also a complaint related to this balloon.See csi complaint (b)(4) to follow.) a second stent was placed in the popliteal.The balloon will be returned.

• Brand Name: JADE
• Type of Device: JADE OTW
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO. LTD; 1 jinkui road; futian free trade zone; shenzhen 518038, shenzhen 518038 51803 8; CH 518038
• Manufacturer (Section G): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.; 1 jinkui road; futian free trade zone; shenzhen 518038, shenzhen 518038 51803 8; CH 518038
• Manufacturer Contact: samantha chan ; 1 jinkui road; futian free trade zone; shenzhen 518038, shenzhen 518038 51803-8 ; CH 518038
• MDR Report Key: 12757294
• MDR Text Key: 280457116
• Report Number: 3003775186-2021-04135
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K202231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 5900522101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male