MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. SAPPHIRE

Device Problem Failure to Advance (2524)

Patient Problem Perforation (2001)

Event Date 05/12/2021

Event Type  Injury  

Event Description

There was difficulty advancing devices across a lesion.An orbusneich sapphire balloon was used to perform angioplasty.When the balloon was inflated, a perforation occurred.The balloon was reported to have been discarded and is not available for return.Additional information has been requested but has not yet been received.

• Brand Name: SAPPHIRE
• Type of Device: SAPPHIRE
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.; no.1st jinkui road; futian free trade zone; shenzhen guangdong,, shenzhen guangdong, CN 51 8038; CH CN 518038
• MDR Report Key: 11926431
• MDR Text Key: 253968345
• Report Number: 3014148220-2021-01792
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/03/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/14/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other