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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. CUTTING/SCORING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER; SCOREFLEX NC SCORING PTCA CATHETER

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ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. CUTTING/SCORING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER; SCOREFLEX NC SCORING PTCA CATHETER Back to Search Results
Model Number 625-104-1U
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation of Vessels (2135)
Event Date 12/07/2022
Event Type  Death  
Event Description
A scoreflex balloon was used to treat a 99% stenosed severely calcified left anterior descending artery (lad).Following angioplasty, a stent was placed in the lesion.Imaging was performed and no anomalies were observed.A non-compliant balloon was used to post-dilate the stent three times.When contrast was injected, a perforation was observed where the stent was placed.Pericardiocentesis was performed, however, the patient passed away.The physician alleged the primary cause of death was due to severe calcification resulting in a minor dissection and perforation.
 
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Brand Name
CUTTING/SCORING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
Type of Device
SCOREFLEX NC SCORING PTCA CATHETER
Manufacturer (Section D)
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
no. 1 jinkui road, futian free
shenzhen, 51803 8
CH  518038
MDR Report Key15931722
MDR Text Key304968086
Report Number3004742232-2022-00307
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 12/07/2022
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
Device Model Number625-104-1U
Device Catalogue Number7-10082-10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/07/2022
Distributor Facility Aware Date11/09/2022
Event Location Other
Date Report to Manufacturer11/18/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/07/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age73 YR
Patient SexFemale
Patient Weight77 KG
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