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 Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2023

Event Type  malfunction  

Event Description

A scoreflex nc scoring balloon was inserted into the left main (lm) coronary artery extending to the left anterior descending (lad) artery.The balloon broke while on the delivery wire.The balloon was removed intact without aid of assistive devices.The device is not expected to return.It was reported as no patient complications.Patient information: 53 years, male, 94kg.Medwatch uf/importer report number: (b)(4).No other information was provided for analysis.Based on the obtained information, there are no signs of manufacturing defects that could be found from this lot of the product.There is no systemic trend identified with regard to this type of event.From case information, it could be presumed that the interaction between the balloon and the calcified lesion during the procedure might cause reported damaged.However, the root cause of this complaint could not be fully ascertained since the product was not returned for analysis and the clinical scenario could not be duplicated in our analysis lab.This complaint has been shared with the manufacturing and engineering teams.We will keep the complaint on file for future statistical analysis and monitoring.No corrective action is required at this time.There is no evidence of a product malfunction, inadequacy in the ifu, or a manufacturing defect.The complaint and analysis will be included in the complaint data reviewed and monitored for this product.

Manufacturer Narrative

This adverse event was reported in esg test system on (b)(6) 2024.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.

Event Description

A scoreflex nc scoring balloon was used to treat a 95% stenosed lesion in the mid left anterior descending (lad) artery.Following a diagnostic angiogram, the guide catheter and the non-csi guide wire were inserted.The scoreflex balloon was advanced into the mid lad lesion.The balloon broke while on the delivery wire.The scoreflex balloon was removed intact without aid of assistive devices and balloon angioplasty was performed using a compliant balloon.The device is expected to return.It was reported as no patient complications; patient information: 53 years, male, 94kg; treated lesion information: 95% stenosed, mid lad; percutaneous entry site: right radial; associated product information: asahi minamo guidewire, boston scientific synergy stent 2.5mmx28mm, sapphire nc balloon 2.75mmx15mm, shockwave balloon 3.0mmx12mm, sapphire nc balloon 3.0mmx18mm; medwatch uf/importer report number: (b)(4).No case/image was provided for analysis.The complaint product, scoreflex nc balloon catheter(2.5x10mm), was returned for evaluation.Microscopic examination revealed that the tip of the returned balloon catheter was elongated and cut lacerated from rx port to the end of the tip, edges of the laceration appeared that the tip material was cut from the inside to outside and consistent with the damage of the guidewire cutting.The balloon catheter was not broken ,no other anomalies were found on the returned balloon catheter.The device history record for this lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.No other similar complaints were received from the same lot products 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.A scoreflex nc sample catheter was taken from production line to carry out a simulation test to duplicate the failure mode.It was found that if the guidewire was pulled by the balloon catheter and an angle was created between the guidewire and the distal tip of the balloon catheter during withdrawal, a loop on the guidewire could be formed.When the distal tip approached the tip of guiding catheter, resistance could be met, the guidewire lumen of the balloon catheter could be cut and lacerated by the guidewire loop.After the analysis of above information, the complaint type is determined as tip damage.From the case report and the failure characteristics of the returned product, the failure mode/appearance is consistent with that a tip was cut lacerated by guidewire.One of the possibilities that could lead to the guidewire loop was the guidewire tangled with the balloon or other devices while the balloon was navigated in tortuous vessels.We recommend that do not apply excessive force when resistance is met during the withdrawal of scoreflex nc and adjust the balloon catheter until resistance is removed.Since a clinical scenario could possibly be duplicated in our analysis lab, a likely cause of this failure was determined to be the guidewire loop cut lacerated the tip.We have forwarded this feedback to manufacturing and engineering teams.We will keep the complaint on file for future statistical analysis and trend monitoring.No corrective action is required at this time.There is no evidence of a product malfunction, inadequacy in the ifu, or a manufacturing defect.The complaint and analysis will be included in the complaint data reviewed and monitored for this product.

• 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: 18900241
• MDR Text Key: 337800400
• Report Number: 3003775186-2023-02473
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 06934955936340
• UDI-Public: (01)06934955936340(11)230722(17)250722(10)3620802307
• 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: User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 625-104-1U
• Device Lot Number: 3620802307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 94 KG