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

Model Number 630-154-1U

Device Problems Burst Container or Vessel (1074); Material Rupture (1546)

Patient Problem Vascular Dissection (3160)

Event Date 08/18/2022

Event Type  Injury  

Event Description

A scoreflex balloon was used following use of a wolverine balloon.The scoreflex balloon was inflated twice at 14 atmospheres in the heavily calcified, 99% stenosed left anterior descending (lad) artery successfully.Afterwards, the balloon was repositioned to the left main (lm) coronary artery and ruptured at 16 atmospheres.Furthermore, dissection was noticed at the rupture site.The dissection was noted where wolverine was used in the ostium and body of lm.Balloon and stent angioplasty was performed to resolve the affected area.The patient was stable during and after the procedure.Additional information received indicated the patient expired due to unrelated organ failure.According to the physician, the patient death was not related to the scoreflex balloon.

Manufacturer Narrative

Return of the device for analysis is anticipated.If the device is received for analysis, a supplemental report will be submitted when the device analysis is completed.As csi is the importer of the orbusneich products, the expiration date, udi, and manufacture date are unavailable.Csi id: (b)(4).On complaint number: (b)(4).

Event Description

A scoreflex balloon was inflated twice at 14 atmospheres in the left anterior descending (lad) artery successfully.Afterwards, the balloon was repositioned to the left main (lm) coronary artery and ruptured at 16 atmospheres.Furthermore, dissection was noticed at the rupture site in the ostium and body of lm.Balloon and stent angioplasty was performed to resolve the affected area.The patient was stable during and after the procedure.Additional information received indicated the patient expired due to organ failure.According to the physician, the patient death was not related to the scoreflex balloon.Related manufacturer report number: 3003775186-2022-02634.

• Brand Name: SCOREFLEX NC SCORING PTCA CATHETER
• Type of Device: CUTTING/SCORING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.; no. 1 jinkui road, futian free; shenzhen, 51803 8; CH 518038
• Manufacturer (Section G): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.; no. 1 jinkui road, futian free; shenzhen, 51803 8; CH 518038
• Manufacturer Contact: tonia moskalets ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 15597913
• MDR Text Key: 301677724
• Report Number: 3004742232-2022-00237
• 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: Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 630-154-1U
• Device Catalogue Number: 630-154-1U
• Device Lot Number: 3614212206
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/11/2022
• Distributor Facility Aware Date: 08/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2022
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic