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U.S. Department of Health and Human Services

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

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ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD SAPPHIRE SAPPHIRE NC PLUS Back to Search Results
Catalog Number 240-153-2U
Device Problem Material Too Rigid or Stiff (1544)
Patient Problems Extravasation (1842); Perforation (2001)
Event Date 03/12/2021
Event Type  Injury  
Event Description
A sapphire balloon was used in the left main (lm) and proximal circumflex (cx) artery as well as with an obtuse marginal lesion following eight atherectomy treatments on low speed. Angiography was performed after atherectomy, and no issues were noticed. Angioplasty and stent placement were performed in the om and cx. Following the second post dilation in the cx with the sapphire balloon, extravasation was noted in the area of the stent. A second balloon was used for tamponade, but the patient responded poorly. A second stent was deployed within the first stent to cover the perforation. The patient then became hemodynamically stable and was eventually transported to the cardiac care unit in stable condition. The procedure was delayed by 30 minutes or more. The patient received additional pressors, and extra saline. The physician stated the sapphire nc plus caused the perforation and that the balloon was too stiff. The physician stated csi's oad did not play a role in the perforation.
 
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Brand NameSAPPHIRE
Type of DeviceSAPPHIRE NC PLUS
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,
Manufacturer (Section G)
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
no.1st jinkui road
futian free trade zone
shenzhen guangdong, shenzhen guangdong CN 51 8038
CH CN 518038
Manufacturer Contact
samantha chan
no.1st jinkui road
futian free trade zone
shenzhen guangdong, shenzhen guangdong CN 51-8038
CH   CN 518038
MDR Report Key11490950
MDR Text Key240022304
Report Number3003775186-2021-00691
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K162209
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 03/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number240-153-2U
Device Lot Number3405792007
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
Date Manufacturer Received03/11/2021
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 Treatment Data
Date Received: 03/16/2021 Patient Sequence Number: 1
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