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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. CSA SAPPHIRE II PRO BALLOON DILATATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. CSA SAPPHIRE II PRO BALLOON DILATATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Catalog Number 210-083-5UU
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/16/2021
Event Type  malfunction  
Event Description
The pt was taken to the lab for successful atherectomy of the right anterior tibial artery. During the procedure, a tip of the sapphire balloon was retained. The fragment was able to be moved closer to the stent. There was no flow-limiting lesion, and the balloon piece was left in situ.
 
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Brand NameCSA SAPPHIRE II PRO BALLOON DILATATION CATHETER
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
MDR Report Key11214197
MDR Text Key228472953
Report NumberMW5098944
Device Sequence Number1
Product Code LOX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 01/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number210-083-5UU
Device Lot Number4220432005
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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