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

Catalog Number 7-10084-80/

Device Problem Burst Container or Vessel (1074)

Patient Problems Pain (1994); Thrombosis/Thrombus (4440)

Event Date 09/03/2021

Event Type  malfunction  

Event Description

A jade otw angioplasty balloon was used during intervention on the right renal artery via left radial approach.An aortogram demonstrated an occluded right renal stent and calcifications to the left renal artery with no evidence of renal artery or parenchymal flow.Intervention was performed on the left renal artery, and a vessel injury there was identified and treated with a stent.The physician then cannulated the right iliac and chose to only perform angioplasty in that area in order to be minimally invasive following the prior vessel injury.The jade balloon was inflated in the common and external iliac arteries sequentially.Inflation was performed as planned in the external iliac artery.Thereafter, the balloon burst at nominal pressure (18atm) in the common iliac.The balloon was removed.However, the distal end of the balloon was captured within the stent.Several unsuccessful attempts were made to remove the distal fragment.Completion of angiogram demonstrated flow down the right common iliac artery.The patient had severe back pain at the end of the operation.The patient was transferred into recovery in stable condition but continued to experience back pain.The patient was admitted to the hospital for a thrombosis unrelated to the reported issue with the balloon.The patient was stable.The balloon had been inadvertently stored in a hot environment (90-99f) prior to use.

• 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, CHN ; CH CHN
• Manufacturer (Section G): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.; 1 jinkui road; futian free trade zone; shenzhen 518038,, shenzhen 518038, CHN ; CH CHN
• Manufacturer Contact: samantha chan ; 1 jinkui road; futian free trade zone; shenzhen 518038,, shenzhen 518038, CHN ; CH CHN
• MDR Report Key: 12531367
• MDR Text Key: 274253214
• Report Number: 3003775186-2021-03513
• 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: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7-10084-80/
• Device Lot Number: 5909972104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2021
• 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