MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. SCOREFLEX CATHETER 3.0 X 10; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/06/2023

Event Type  Injury  

Event Description

Multi-vessel disease with lad(left anterior descending artery) 100% chronic total occlusion visualized with angiography.Decision was to perform invasive coronary intervention with iabp(intra-aortic balloon pump) assistance.Initial placement of iabp prior to intervention.Multiple attempts were made to deliver cutting balloons to better prepare the lesion.Unfortunately, both 3.0 x 10 scoreflex and 3.0x10 wolverine balloons would not cross the lesion.A 2.5x15 nc sapphire was advanced beyond the lesion and serially dilated the lesion.During our final inflation it was noted that the balloon had burst, prompting attempted removal of the balloon and catheter from the body.Unfortunately, the balloon was unable to be removed due to entrainment within the wall of the artery/cto(chronic total occlusion).Attempts were made to remove the balloon fragments through utilization of a 6f guideliner to remove the embedded balloon from the arterial wall, but this was unsuccessful.A buddy wire system was then used to attempt to free the balloon fragments, but this was also unsuccessful.Attempts were made to balloon-dilate the lesion to permit delivery of larger equipment for potential downstream stent delivery, but this was unable to be delivered beyond the lesion.At this point, consultation with cvs (cardiovascular) was requested.Attempts were made to remove the remainder of the balloon catheter which was only partially successful and led to separation of the proximal and distal portions of the balloon.Multiple unsuccessful attempts were made to remove the distal portion of the balloon.Angiography was obtained and 95% residual stenosis with timi-2 (thrombolysis in myocardial infarction grade 2) flow was resulted.At this point the procedure was terminated with plans for acb (aortocoronary bypass) evaluation.Reference reports: mw5145560, mw5145562.

• Brand Name: SCOREFLEX CATHETER 3.0 X 10
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
• MDR Report Key: 17735376
• MDR Text Key: 323491328
• Report Number: MW5145561
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White