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

Catalog Number	640-204-1U
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	08/13/2024
Type of Reportable Event	Death
Event or Problem Description
The treated area was an 85% stenosed, heavily calcified distal to proximal left anterior descending (lad).Following the placement of an impella, the scoreflex balloon was advanced with the aid of a cordis 7fr guiding catheter.The scoreflex balloon was inflated twice to nominal pressure.Angiographic imaging was taken, and a perforation was observed.The exact location of the perforation in the lad could not be determined.The patient coded, and cardiopulmonary resuscitation (cpr) was performed, intubation and medication were administered.The patient stabilized, and three papyrus covered stents were placed to treat the perforation.The patient was transferred to intensive care unit (icu) for further observation.It was the physician's opinion the patient's heavy calcification caused the perforation; the calcium caused injury to the patient when the scoreflex balloon was inflated.Additional information received on 8/20/2024, the patient expired.
Event or Problem Description
Additional information was received on 2024/8/28 regarding this case (crf#(b)(4)) as follows, 1.The patient expired on (b)(6) 2024.2.In the opinion of the physician, perforation is the primary and secondary cause of death.3.In the opinion of the physician, the orbusneich device did not cause or contribute to the patient's death.4.Why does the physician believe the orbusneich device did not cause or contribute to the patient's death? per physician "the patient had highly calcified lesions.The rupture could have been caused by anything used to break that calcium." so, we submit a followup report to complete this case.

• Brand Name: SCOREFLEX NC SCORING PTCA CATHETER
• Common Device Name: 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: 20045313
• Report Number: 3003775186-2024-00313
• Device Sequence Number: 18136992
• Product Code: NWX
• UDI-Device Identifier: 06934955936487
• UDI-Public: (01)06934955936487(11)230708(17)250708(10)3619092306
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: P200041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 640-204-1U
• Device Lot Number: 3619092306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female