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

Catalog Number 625-104-1U

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Vascular Dissection (3160)

Event Date 11/06/2023

Event Type  Injury  

Event Description

A scoreflex balloon was advanced over a guide wire and inflated slowly to 10 atmospheres (atm) for one minute, then slowly deflated.An angiogram was used to determine the balloon needed to be advanced three to five millimeters.The balloon was inflated slowly to 10 atmospheres for 30 seconds, and then slowly deflated.The physician attempted to remove the balloon, but the wire was coming back with the balloon.The balloon was unable to be removed without the wire, as it was wrapped around the balloon.Another angiogram was observed, and it was noticed there was a dissection on the diagonal.An abbott whisper wire was attempted to be used, but kept getting caught in the dissection.After multiple attempts, the physician was able to re-cross the diagonal with the balloon and a 2.5x18 onyx stent was placed in the lesion and dissection.

Manufacturer Narrative

This adverse event was reported in esg test system on 2023/11/24 (mfr report #: 3003775186-2023-02286).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 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: 18947215
• MDR Text Key: 338184490
• Report Number: 3003775186-2023-02286
• 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: 03/19/2024

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 Catalogue Number: 625-104-1U
• Device Lot Number: 3618442207
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 03/20/2024
• 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): Life Threatening
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 82 KG