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

Model Number	622-204-1U
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	Reduced Blood Flow (4598)
Date of Event	06/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
While picking up the balloon for product return, the abbott sales representative observed a mid-distal kink in the shaft of the balloon.It is unknown when the kink occurred.Csi id: (b)(4).
Event or Problem Description
A scoreflex nc scoring balloon was used for treatment of a heavily calcified, 85% stenosed lesion in mid left anterior descending (lad) artery via right radial approach.A 6fr guiding catheter was used to deploy the balloon to the lesion.No resistance was felt while advancing the balloon.The scoreflex was inflated at nominal pressure in mid lad artery totally occluding it.The scoreflex could not be deflated.Using different indeflators, syringes and other unspecified devices did not resolve the issue.Wire cutters from the operating room (or) were used to cut the balloon shaft at the hub to get it to deflate but the balloon remained inflated.A guide extension catheter was placed over the cut shaft to wedge the balloon down as much as possible.With some gentle pulling, they were able to get the balloon to the guide extension catheter and pulled the whole system out together.To complete the procedure, balloon angioplasty and stent placement were performed using abbott bmw guide wire for device delivery.There was a three-minute delay to the procedure but no harm to the patient.

• Brand Name: SCOREFLEX NC SCORING PTCA CATHETER
• Common Device Name: PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA)
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.; no. 1 jinkui road, futian free; shenzhen, 51803 8; CH 518038
• MDR Report Key: 19671138
• Report Number: 3004742232-2024-00249
• Device Sequence Number: 3166099
• Product Code: LOX
• UDI-Device Identifier: 06934955936333
• UDI-Public: 01069349559363331123020417250204103600562301
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/03/2024
• Report Date (Section F): 06/18/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/04/2025
• Device Model Number: 622-204-1U
• Device Catalogue Number: 7-10082-09
• Device Lot Number: 3600562301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/07/2024
• Device Age: 17 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/03/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male