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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. SAPPHIRE II PRO PTCA BALLOON

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ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. SAPPHIRE II PRO PTCA BALLOON Back to Search Results
Catalog Number 210-1035UU
Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/22/2020
Event Type  malfunction  
Event Description
During advancement through a stent to treat a lesion, the sapphire ii pro balloon tore and the tip came off the end. The procedure was continued successfully with a second sapphire balloon.
 
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Brand NameSAPPHIRE II PRO
Type of DevicePTCA BALLOON
Manufacturer (Section D)
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
no.1st jinkui road
futian free trade zone
shenzhen guangdong, shenzhen guangdong CN 5 1803
CH CN 518038
Manufacturer (Section G)
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
no.1st jinkui road
futian free trade zone
shenzhen guangdong,, shenzhen guangdong, CN 5 1803
CH CN 518038
Manufacturer Contact
samantha chan
no.1st jinkui road
futian free trade zone
shenzhen guangdong, shenzhen guangdong CN 5-1803
CH   CN 518038
MDR Report Key10045839
MDR Text Key208425202
Report Number3003775186-2020-01643
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K173680
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 05/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number210-1035UU
Device Lot Number4251161909
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/01/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/11/2020 Patient Sequence Number: 1
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