MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD SCOREFLEX NC SCORING PTCA CATHETER; Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring

Catalog Number 640-104-1U

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 02/12/2024

Event Type  Injury  

Event Description

A heavily calcified proximal left anterior descending artery (lad) was the target treatment area.Following shockwave intravascular lithotripsy (ivl) and skypoint stent placement a trek nc balloon was advanced for post dilation then the scoreflex balloon was advanced, with the aid of a run through nc guide wire and inflated to 12 atmosphere pressure (atm) and removed.Optical coherence tomography (oct) and angiography were checked, and a perforation was observed.Angioplasty was performed using new trek balloon to treat the perforation but was unsuccessful.Ecmo and empella were performed, and a new run through guide wire was advanced, and an onyx stent was placed to treat the perforation.The patient was stable and transferred to a different facility for bypass surgery.The physician's opinion was that the patient's heavily calcified artery was a factor to why the perforation occurred but could not say which one device caused or contributed to the perforation.It was noted that the vessel was not prepped properly by using an oversized skypoint stent.Background: there were patient complications: perforation patient status: satisfactory patient information: 67 years, male treated lesion information: lad, heavily calcified no case image/cd was provided for analysis.We report this case out of an abundance of caution.

• Brand Name: SCOREFLEX NC SCORING PTCA CATHETER
• Type of Device: Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD; no.1st jinkui road; futian free trade zone; shenzhen, guangdong 51803 8; CH 518038
• Manufacturer (Section G): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD; no.1st jinkui road; futian free trade zone; shenzhen, guangdong 51803 8; CH 518038
• Manufacturer Contact: yuki li ; no.1st jinkui road; futian free trade zone; shenzhen, guangdong 51803-8 ; CH 518038
• MDR Report Key: 18823565
• MDR Text Key: 336740986
• Report Number: 3003775186-2024-00099
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 640-104-1U
• Device Lot Number: 3610862304
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2024
• 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 Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Male