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

Catalog Number 635-154-1U

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

Patient Problem Perforation of Vessels (2135)

Event Date 04/24/2023

Event Type  Injury  

Event Description

The scoreflex balloon was used for treatment in the mid left anterior descending artery (lad), in stent restenosis (isr).Intravascular ultrasound showed the vessel was 4.2 mm.The scoreflex balloon was advanced, with the aid of a asahi scion blue guide wire, and inflated to 20 atmosphere pressure (atm).A perforation occurred through the stent.The perforation was treated with a biotronik papyrus covered stent and pericardiocentesis was performed with minimal blood loss.The flow to the lad was good.Patient is stable and will undergo permanent pacemaker placement surgery later today.No damage or issues were observed to the balloon.Since neither the involved device nor the image/cd of the procedure was provided for evaluation, the investigation was limited to the review of our facility quality records.A review of the manufacturing records for this lot did not reveal any non-conformities which could have contributed to the complaint.No other similar complaints have been received from this lot up to now.Orbusneich medical manufacturing processes include extensive testing and inspections to ensure each product meets all material, assembly, and performance specifications prior to release.After the analysis of complaint information, the complaint type is determined as clinical event.Since neither the involved device nor the image/cd of the procedure was provided for evaluation, the investigation was limited to the review of our facility quality records.A review of the manufacturing records for this lot did not reveal any non-conformities which could have contributed to the complaint.No other similar complaints have been received from this lot up to now.Orbusneich medical manufacturing processes include extensive testing and inspections to ensure each product meets all material, assembly, and performance specifications prior to release.After the analysis of complaint information, the complaint type is determined as clinical event.Since neither the involved device nor the image/cd of the procedure was provided for evaluation, the investigation was limited to the review of our facility quality records.A review of the manufacturing records for this lot did not reveal any non-conformities which could have contributed to the complaint.No other similar complaints have been received from this lot up to now.Orbusneich medical manufacturing processes include extensive testing and inspections to ensure each product meets all material, assembly, and performance specifications prior to release.After the analysis of complaint information, the complaint type is determined as clinical event.

Manufacturer Narrative

This adverse event was reported in esg test system on (b)(6) 2023 (mfr report #: 3003775186-2023-00986).Since we realize it is not correct to report it in the test system, we now take the corrective action to submit this report in the production system.This adverse event is an individual case and per our investigation, it is concluded that there is no evidence of a product malfunction, inadequacy in the ifu, or a manufacturing defect regarding this event.We have taken corrective and preventive actions in our company to correct the wrong reporting issue and prevent this issue from re-occurring in the future.

• Brand Name: SCOREFLEX NC CORONARY DILATATION 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, chn 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: air xu ; no.1st jinkui road; futian free trade zone; shenzhen, guangdong 51803-8 ; CH 518038
• MDR Report Key: 18947213
• MDR Text Key: 338186295
• Report Number: 3003775186-2023-00986
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P200041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 635-154-1U
• Device Lot Number: 3631892210
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2023
• 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): Life Threatening
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 70 KG